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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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2DEG SLOPE RECUT BLK .050 IN - 00889024660564

No Description
Zimmer, Inc.
SSI007338
In Commercial Distribution

  • 00889024660564 ()

  • 2DEG .050 IN
SSI007338

  • Orthopaedic prosthesis implantation positioning instrument, reusable

TITAN™ - 10381780258346

Central Anti-Rotation Peg
Ascension Orthopedics, Inc.
PEG-0926-000
In Commercial Distribution

  • M269PEG09260001 ()
  • 10381780258346 ()

  • 1.13 in L


  • Orthopaedic implant-instrument extension adaptor, reusable

Integra® - 10381780248149

Integra® External Fixation System The wire tensioner is used to apply tension to the wires after they are run through the bone and attached to the ring.
Ascension Orthopedics, Inc.
12225300
In Commercial Distribution

  • M269122253001 ()
  • 10381780248149 ()

  • .004 in opening
12225300

  • External orthopaedic fixation system, reusable

Integra® - 10381780248132

Integra® External Fixation System The provisional midfoot support is used with the external fixation system.
Ascension Orthopedics, Inc.
12225060
In Commercial Distribution

  • M269122250601 ()
  • 10381780248132 ()

  • 5.702 in L
12225060

  • External orthopaedic fixation system, reusable

Integra® - 10381780248125

Integra® External Fixation System The provisional heel support is used with the external fixation system.
Ascension Orthopedics, Inc.
12225050
In Commercial Distribution

  • M269122250501 ()
  • 10381780248125 ()

  • 6.238 in L
12225050

  • External orthopaedic fixation system, reusable

Integra® - 10381780248118

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® - 10381780247975

Integra® External Fixation System The k-wire guide is used during strut assembly in the external fixation system.
Ascension Orthopedics, Inc.
12225315
In Commercial Distribution

  • M269122253151 ()
  • 10381780247975 ()

  • 2.56 in L
12225315

  • Orthopaedic guidewire, reusable

Integra® - 10381780247951

Integra® Titanium Bone Wedge System The Cotton Wedge Trial Caddy is a smaller, removable container with a lid that can rest within the base.
Ascension Orthopedics, Inc.
CSA-1006-04
Not in Commercial Distribution

  • M269CSA1006041 ()
  • 10381780247951 ()

  • 6.625 in L
CSA100604

  • Instrument tray, reusable

Integra® - 10381780247937

Integra® Titanium Bone Wedge System The LCL Wedge Trial Caddy is a smaller, removable container with a lid that can rest within the base.
Ascension Orthopedics, Inc.
CSA-1006-02
Not in Commercial Distribution

  • M269CSA1006021 ()
  • 10381780247937 ()

  • 6.625 in L
CSA100602

  • Instrument tray, reusable

Integra® - 10381780247906

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
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