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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Integra® - 10381780246992

Integra®Surgical Instruments The Kolbel retractor is used to withdraw muscle and tissue for exposure.
Ascension Orthopedics, Inc.
RET92061XL
In Commercial Distribution

  • M269RET92061XL1 ()
  • 10381780246992 ()

  • X-Large
RET-920-61XL

  • Surgical retractor/retraction system blade, reusable

Integra® - 10381780246985

Integra®Surgical Instruments The Kolbel retractor is used to withdraw muscle and tissue for exposure.
Ascension Orthopedics, Inc.
RET92061S
In Commercial Distribution

  • M269RET92061S1 ()
  • 10381780246985 ()

  • Small
RET-920-61S

  • Surgical retractor/retraction system blade, reusable

Integra® - 10381780246978

Integra®Surgical Instruments The Kolbel retractor is used to withdraw muscle and tissue for exposure.
Ascension Orthopedics, Inc.
RET92061L
In Commercial Distribution

  • M269RET92061L1 ()
  • 10381780246978 ()

  • Large
RET-920-61L

  • Surgical retractor/retraction system blade, reusable

Titan™ - 10381780245841

Titan™ Total Shoulder System The stand insert is used as a base during head impaction.
Ascension Orthopedics, Inc.
IS0920071STD
In Commercial Distribution

  • M269INS0920071STD1 ()
  • 10381780245841 ()

  • Standard
INS-0920-071-STD

  • Surgical implant/trial-implant/sizer holder, reusable

Titan™ - 10381780245612

Titan™ Reverse Shoulder System The IM head cutting guide is used during implant head resection.
Ascension Orthopedics, Inc.
IMC096004301
In Commercial Distribution

  • M269IMC0960043011 ()
  • 10381780245612 ()

  • 2.06 in L
IMC-0960-043-01

  • Custom-made orthopaedic/craniofacial surgical guide

Titan™ - 10381780245469

Titan™ Total Shoulder System The glenoid drill shaft is used with the total shoulder system.
Ascension Orthopedics, Inc.
HDL092208201
In Commercial Distribution

  • M269HDL0922082011 ()
  • 10381780245469 ()
HDL-0922-082-01

  • Cannulated surgical drill bit, reusable

Construct® - 10381780245346

Construct® Ankle Fusion Plate System The Smith Peterson straight osteotome is used for cutting bone.
Ascension Orthopedics, Inc.
gS 52.5520
Not in Commercial Distribution

  • M269GS5255201 ()
  • 10381780245346 ()

  • .75 in W
gS 52.5520

  • Orthopaedic osteotome

Ti6® Internal Fixation System - 10381780244769

Integra® Ti6® The ratchet handle is used in conjunction with the Digital Fusion screws.
Ascension Orthopedics, Inc.
DS1007
In Commercial Distribution

  • M269DS10071 ()
  • 10381780244769 ()

  • 5.92 in L
DS1007

  • Surgical instrument handle, non-torque-limiting

Titan™ - 10381780244660

Titan™ Reverse Shoulder System The baseplate boss drill is used with the reverse shoulder system.
Ascension Orthopedics, Inc.
DRL096007501
In Commercial Distribution

  • M269DRL0960075011 ()
  • 10381780244660 ()

  • .320 in major dia; .424 in L thread
DRL-0960-075-01

  • Cannulated surgical drill bit, single-use

Integra® - 10381780244653

Integra®Surgical Instruments The drill bit is a cutting tool used to create cylindrical holes.
Ascension Orthopedics, Inc.
DRL096006801
In Commercial Distribution

  • M269DRL0960068011 ()
  • 10381780244653 ()

  • 6.0 in L x .110 in dia tip
DRL-0960-068-01

  • Cannulated surgical drill bit, single-use
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