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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® - 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

Titan™ - 10381780247586

Titan™ Total Shoulder System The head cutting template has a right orientation. It is used for head resection.
Ascension Orthopedics, Inc.
T0920040001R
In Commercial Distribution

  • M269TMP0920040001R1 ()
  • 10381780247586 ()

  • 3.0 in L
TMP-0920-040-001R

  • Surgical implant template, reusable

Titan™ - 10381780247579

Titan™ Total Shoulder System The head cutting template has a left orientation. It is used for head resection.
Ascension Orthopedics, Inc.
T0920040001L
In Commercial Distribution

  • M269TMP0920040001L1 ()
  • 10381780247579 ()

  • 3.0 in L
TMP-0920-040-001L

  • Surgical implant template, reusable

Titan™ - 10381780247371

Titan™ Reverse Shoulder System The torx-25 screwdriver shaft with quick connect is used to advance the screw just before it is fully seated.
Ascension Orthopedics, Inc.
SCR096007201
In Commercial Distribution

  • M269SCR0960072011 ()
  • 10381780247371 ()

  • 9.80 in L
SCR-0960-072-01

  • Surgical screwdriver, reusable

Titan™ - 10381780247364

Titan™ Reverse Shoulder System The slotted torx-15 for 4.5mm screw locking caps is used to thread and tighten the locking caps directly over the superior and inferior screw heads.
Ascension Orthopedics, Inc.
SCR096006301
In Commercial Distribution

  • M269SCR0960063011 ()
  • 10381780247364 ()

  • 5.5 in L
SCR-0960-063-01

  • Surgical screwdriver, reusable

Integra® - 10381780247333

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
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