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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® External Fixation System The provisional calf support is used with the external fixation system.
Ascension Orthopedics, Inc.
12225040
In Commercial Distribution

  • M269122250401 ()
  • 10381780248118 ()

  • 6.883 in L
12225040

  • External orthopaedic fixation system, reusable
Integra® Titanium Bone Wedge System The tamp is used to impact the implant into place.
Ascension Orthopedics, Inc.
TMP-1006-00
Not in Commercial Distribution

  • M269TMP1006001 ()
  • 10381780247906 ()

  • 6.0 in L
TMP100600

  • Surgical tamp, reusable
Integra® Ti6® TheTi6 Sterilization Tray Base is the bottom portion wherein devices are placed.
Ascension Orthopedics, Inc.
TT1000
In Commercial Distribution

  • M269TT10001 ()
  • 10381780247753 ()

  • 6.97in L x 5.80in W x 1.50in H
TT1000

  • Instrument tray, reusable
Titan™ Total Shoulder System The taper disassembly tool is used in the total shoulder system.
Ascension Orthopedics, Inc.
TT0920044001
In Commercial Distribution

  • M269TDT09200440011 ()
  • 10381780247555 ()

  • 4.0 in L x 1.0 in H
TDT-0920-044-001

  • Orthopaedic implant/instrument assembling device
Integra®Surgical Instruments The 1/8 Hex Driver is used to tighten or loosen screws.
Ascension Orthopedics, Inc.
SR0920060001
In Commercial Distribution

  • M269SCR09200600011 ()
  • 10381780247333 ()

  • 5.5 in L
SCR-0920-060-001

  • Surgical screwdriver, reusable
Integra®Surgical Instruments The Integra Surgical Instruments mini ratchet handle is provided green in color.
Ascension Orthopedics, Inc.
RM1011S03
In Commercial Distribution

  • M269RM1011S031 ()
  • 10381780247043 ()

  • 5.51 in L
RM1011-S03

  • Surgical instrument handle, non-torque-limiting
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®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®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™ 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
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