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OSSDSIGN Cranial PSI Accessories are optional devices that support physician use of the OSSDSIGN Cranial PSI (K161090) parent device. They are additively manufactured from PA2200 polyamide material. Each Cranial PSI Accessory is patient-specific and corresponds to a patient’s unique anatomical requirements. Cranial PSI Accessories are intended to support implantation of the corresponding Cranial PSI parent device; both devices are designed from the same patient-specific computed tomography image data set. (510(k) no. K190523)
Ossdsign AB
S
Not in Commercial Distribution
- 17350086550648 ()
- 07350086550641 ()
- Custom-made orthopaedic surgical guide, sterile
OSSDSIGN Cranial PSI Accessories are optional devices that support physician use of the OSSDSIGN Cranial PSI (K161090) parent device. They are additively manufactured from PA2200 polyamide material. Each Cranial PSI Accessory is patient-specific and corresponds to a patient’s unique anatomical requirements. Cranial PSI Accessories are intended to support implantation of the corresponding Cranial PSI parent device; both devices are designed from the same patient-specific computed tomography image data set. (510(k) no. K190523)
Ossdsign AB
XL
Not in Commercial Distribution
- 17350086550631 ()
- 07350086550634 ()
- Custom-made orthopaedic surgical guide, sterile
OSSDSIGN Cranial PSI Accessories are optional devices that support physician use of the OSSDSIGN Cranial PSI (K161090) parent device. They are additively manufactured from PA2200 polyamide material. Each Cranial PSI Accessory is patient-specific and corresponds to a patient’s unique anatomical requirements. Cranial PSI Accessories are intended to support implantation of the corresponding Cranial PSI parent device; both devices are designed from the same patient-specific computed tomography image data set. (510(k) no. K190523)
Ossdsign AB
L
Not in Commercial Distribution
- 17350086550624 ()
- 07350086550627 ()
- Custom-made orthopaedic surgical guide, sterile
OSSDSIGN Cranial PSI Accessories are optional devices that support physician use of the OSSDSIGN Cranial PSI (K161090) parent device. They are additively manufactured from PA2200 polyamide material. Each Cranial PSI Accessory is patient-specific and corresponds to a patient’s unique anatomical requirements. Cranial PSI Accessories are intended to support implantation of the corresponding Cranial PSI parent device; both devices are designed from the same patient-specific computed tomography image data set. (510(k) no. K190523)
Ossdsign AB
M
Not in Commercial Distribution
- 17350086550617 ()
- 07350086550610 ()
- Custom-made orthopaedic surgical guide, sterile
OSSDSIGN Cranial PSI Accessories are optional devices that support physician use of the OSSDSIGN Cranial PSI (K161090) parent device. They are additively manufactured from PA2200 polyamide material. Each Cranial PSI Accessory is patient-specific and corresponds to a patient’s unique anatomical requirements. Cranial PSI Accessories are intended to support implantation of the corresponding Cranial PSI parent device; both devices are designed from the same patient-specific computed tomography image data set. (510(k) no. K190523)
Ossdsign AB
S
Not in Commercial Distribution
- 17350086550600 ()
- 07350086550603 ()
- Custom-made orthopaedic surgical guide, sterile
The Qlicksmart BladeSINGLE scalpel blade remover is simple to use with a quick “push, click, and pull” action to remove and contain used scalpel blades. Used together with a hands-free passing technique, the Qlicksmart BladeSINGLE scalpel blade remover can prevent up to 5 times more injuries than a safety scalpel. This easy-to-use solution provides a low cost alternative to safety scalpels, allowing surgeons to maintain their preferences for the standard metal handle.
QLICKSMART PTY LTD
QSBS01
In Commercial Distribution
- 29337363001616 ()
- 19337363001619 ()
- 09337363001612 ()
- Scalpel blade remover, sterile
The Qlicksmart BladeSINGLE scalpel blade remover is simple to use with a quick “push, click, and pull” action to remove and contain used scalpel blades. Used together with a hands-free passing technique, the Qlicksmart BladeSINGLE scalpel blade remover can prevent up to 5 times more injuries than a safety scalpel. This easy-to-use solution provides a low cost alternative to safety scalpels, allowing surgeons to maintain their preferences for the standard metal handle.
QLICKSMART PTY LTD
QSBS01
In Commercial Distribution
- 29337363001456 ()
- 19337363001459 ()
- 09337363001452 ()
- Scalpel blade remover, sterile
AS-915 Anaerobic Tissue Transport Medium - Surgery Pack (ATTM-SP) is a mineral salt based semi-solid media with reducing agents. Designed as a holding medium to maintain the viability of microorganisms, both anaerobic and aerobic, through collection, transportation, and shipment of clinical specimens. Individually packaged and sterilized for use in a surgical setting. Pre-reduced anaerobically sterilized (PRAS). 8 mL fill volume. 28 x 57 mm screw top vial. Transparent colorless semi-solid medium. 5 tubes per pack.
ANAEROBE SYSTEMS
AS-915
In Commercial Distribution
- 00810048901432 ()
- 00810048901425 ()
AS-915
- Anaerobic transport medium IVD
"The GSS Pedicle Screw System is a top-loading multiple component, posterior spinal fixation system which consists of pedicle screws, rods, locking spacer, and a transverse (cross) linking mechanism. The GSS Pedicle Screw System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The GSS Pedicle Screw System implant components are supplied non-sterile, single use and fabricated from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F136. Various sizes of these implants are available. Specialized instruments are available for the application and removal of the GSS Pedicle Screw System.
The GSS Pedicle Screw System is a pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-SI vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion."
GS Medical Co., Ltd.
GS0122-6540
Not in Commercial Distribution
- 08806162101522 ()
GS0122-6540
- Bone-screw internal spinal fixation system, non-sterile
"The GSS Pedicle Screw System is a top-loading multiple component, posterior spinal fixation system which consists of pedicle screws, rods, locking spacer, and a transverse (cross) linking mechanism. The GSS Pedicle Screw System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The GSS Pedicle Screw System implant components are supplied non-sterile, single use and fabricated from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F136. Various sizes of these implants are available. Specialized instruments are available for the application and removal of the GSS Pedicle Screw System.
The GSS Pedicle Screw System is a pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-SI vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion."
GS Medical Co., Ltd.
GS0122-5535
Not in Commercial Distribution
- 08806162101515 ()
GS0122-5535
- Bone-screw internal spinal fixation system, non-sterile