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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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Modular Radial Head Osteotomy Cut Guide, MRH
Ascension Orthopedics, Inc.
OSG35001
In Commercial Distribution

  • M269OSG350011 ()
  • 10381780246466 ()

  • 6.0 in L
OSG-350-01

  • Custom-made orthopaedic/craniofacial surgical guide
PyroCarbon PIP Total Joint PIP Vertical Cut Guide
Ascension Orthopedics, Inc.
OSG20000
In Commercial Distribution

  • M269OSG200001 ()
  • 10381780246374 ()

  • 2.39 in L
OSG-200-00

  • Custom-made orthopaedic/craniofacial surgical guide
Ascension® MCP Osteotomy Guide, Proximal
Ascension Orthopedics, Inc.
OSG10000P
In Commercial Distribution

  • M269OSG10000P1 ()
  • 10381780246367 ()

  • 2.04 in L
OSG-100-00P

  • Orthopaedic reamer guide
Ascension® MCP Osteotomy Guide, Distal
Ascension Orthopedics, Inc.
OSG10000D
In Commercial Distribution

  • M269OSG10000D1 ()
  • 10381780246350 ()

  • 2.48 in L
OSG-100-00D

  • Orthopaedic reamer guide
Integra® MemoFix® Staple System The MemoFix removal tool is used to remove staples by lifting the staple bridge to a position in which the staple spreader can be engaged.
Ascension Orthopedics, Inc.
MS-2940
In Commercial Distribution

  • M269MS29401 ()
  • 10381780246251 ()

  • 3.5 in L
MS-2940

  • Orthopaedic inorganic implant inserter/extractor, reusable
Integra® MemoFix® Staple System The MemoFix tamp is used to push down the staple into the bone.
Ascension Orthopedics, Inc.
MS-2920
In Commercial Distribution

  • M269MS29201 ()
  • 10381780246237 ()

  • 6.02 in L
MS-2920

  • Surgical tamp, reusable
Titan™ Reverse Shoulder System The reamer guide body inserter/extractor is used to assist with the preparation and placement of trials and implants in the reverse shoulder system.
Ascension Orthopedics, Inc.
INS096004901
In Commercial Distribution

  • M269INS0960049011 ()
  • 10381780245858 ()

  • 8.63 in L
INS-0960-049-01

  • Orthopaedic inorganic implant inserter/extractor, reusable
Titan™ Reverse Shoulder System The stand is used as a base during stem impaction.
Ascension Orthopedics, Inc.
IMS096007001
In Commercial Distribution

  • M269IMS0960070011 ()
  • 10381780245810 ()

  • 2.2 in H
IMS-0960-070-01

  • Surgical implant/trial-implant/sizer holder, reusable
Humeral Resurfacing Arthroplasty
Ascension Orthopedics, Inc.
IMP90001
In Commercial Distribution

  • M269IMP900011 ()
  • 10381780245803 ()

  • 6.33 in L
IMP-900-01

  • Orthopaedic implant impactor, reusable
Titan™ Reverse Shoulder System Liner Impactor The Liner Impactor is used to properly fit the liner into place.
Ascension Orthopedics, Inc.
IMP096007101
In Commercial Distribution

  • M269IMP0960071011 ()
  • 10381780245674 ()

  • 8.43 in L
IMP-0960-071-01

  • Orthopaedic implant impactor, reusable
Titan™ Reverse Shoulder System Glenosphere Impactor The Glenosphere Impactor is used to properly fit the implant and/or trial into the prepared cavity.
Ascension Orthopedics, Inc.
IMP096006601
In Commercial Distribution

  • M269IMP0960066011 ()
  • 10381780245667 ()

  • 8.79 in L
IMP-0960-066-01

  • Orthopaedic implant impactor, reusable
Titan™ Reverse Shoulder System The Glenoid Baseplate Impactor is used to properly fit the implant and/or trial into the prepared cavity.
Ascension Orthopedics, Inc.
IMP096006401
In Commercial Distribution

  • M269IMP0960064011 ()
  • 10381780245650 ()

  • 8.26 in L
IMP-0960-064-01

  • Orthopaedic implant impactor, reusable
Titan™ Total Shoulder System IMPACTOR, HEAD, TSS The Head Impactor is used to properly fit the implant and/or trial into the prepared cavity.
Ascension Orthopedics, Inc.
IP0920079501
In Commercial Distribution

  • M269IMP09200795011 ()
  • 10381780245643 ()

  • 6.24 in L
IMP-0920-0795-01

  • Orthopaedic implant impactor, reusable
Titan™ Total Shoulder System Glenoid Impactor The Glenoid Impactor is used to properly fit the implant and/or trial into the prepared cavity.
Ascension Orthopedics, Inc.
IP0920064001
In Commercial Distribution

  • M269IMP09200640011 ()
  • 10381780245636 ()

  • 8.8 in L
IMP-0920-064-001

  • Orthopaedic implant impactor, reusable
Titan™ Total Shoulder System Stem Impactor The Stem Impactor is placed over the implant stem to impact it into the canal for press fit.
Ascension Orthopedics, Inc.
IP0920055001
In Commercial Distribution

  • M269IMP09200550011 ()
  • 10381780245629 ()

  • 4.3 in L
IMP-0920-055-001

  • Orthopaedic implant impactor, reusable
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™ Total Shoulder System Mini Glenoid Holder
Ascension Orthopedics, Inc.
HDR-0940-048-001
In Commercial Distribution

  • M269HDR09400480011 ()
  • 10381780245551 ()

  • 9.9 in L
HDR-0940-048-001

  • Orthopaedic implant/instrument assembling device
Integra® BioMotion® Cannulated Hemi System The slide hammer is used to assist with implant placement into the bone.
Ascension Orthopedics, Inc.
HM 3010
In Commercial Distribution

  • M269HM30101 ()
  • 10381780245513 ()

  • 8.14 in L
HM 3010

  • Orthopaedic implant impactor, reusable
Integra® BioMotion® Cannulated Hemi System BioMotion Slide Broach The BioMotion Slide Broach is used to prepare a cavity that provides a press fit for the implant.
Ascension Orthopedics, Inc.
HM 3005
In Commercial Distribution

  • M269HM30051 ()
  • 10381780245506 ()

  • 8.24 in L
HM 3005

  • Orthopaedic broach
Titan™ Total Shoulder System The humeral depth stop is used for precise measurement.
Ascension Orthopedics, Inc.
HS0920069001
In Commercial Distribution

  • M269HDS09200690011 ()
  • 10381780245490 ()

  • .76 in W
HDS-0920-069-001

  • Surgical depth gauge, reusable
Titan™ Total Shoulder System The anti-rotation peg holder is used to assist with the placement of the anti-rotation peg in the Titan Total Shoulder system.
Ascension Orthopedics, Inc.
HL0920075001
In Commercial Distribution

  • M269HDL09200750011 ()
  • 10381780245452 ()

  • 8.5 in L
HDL-0920-075-001

  • Orthopaedic implant/instrument assembling device
Titan™ Total Shoulder System The stem trial handle is used to assist with the placement of the stem trial.
Ascension Orthopedics, Inc.
HL0920043001
In Commercial Distribution

  • M269HDL09200430011 ()
  • 10381780245445 ()

  • 6.35 in L
HDL-0920-043-001

  • Surgical instrument handle, non-torque-limiting
Construct® Ankle Fusion Plate System The guide pin targeting sleeve is attached to the guide pin targeting base in the Construct Ankle Fusion Plate System.
Ascension Orthopedics, Inc.
GTS-1000-01
Not in Commercial Distribution

  • M269GTS1000011 ()
  • 10381780245407 ()

  • 3.0 in L
GTS100001

  • Surgical drill guide, reusable
Construct® Ankle Fusion Plate System The targeting base knob is used in the Construct Ankle Fusion Plate System.
Ascension Orthopedics, Inc.
GTB-1000-03
Not in Commercial Distribution

  • M269GTB1000031 ()
  • 10381780245391 ()

  • 1.935 in L
GTB-1000-03

  • Orthopaedic implant/instrument assembling device
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
Integra®Surgical Instruments The Guide Pin is used in conjunction with the cup and cone reamers.
Ascension Orthopedics, Inc.
GDW-895-00
In Commercial Distribution

  • M269GDW895001 ()
  • 10381780245308 ()

  • 6.0 in L
GDW-895-00

  • Orthopaedic guidewire, reusable
Titan™ Total Shoulder System The head cutting depth gauge can be used to assess the cutting plane.
Ascension Orthopedics, Inc.
GU0920058001
In Commercial Distribution

  • M269GAU09200580011 ()
  • 10381780245278 ()

  • 5.25 in L
GAU-0920-058-001

  • Surgical depth gauge, reusable
Integra®Surgical Instruments The torque limiter is used during assembly and implantation of devices.
Ascension Orthopedics, Inc.
G207153
In Commercial Distribution

  • M269G2071531 ()
  • 10381780245261 ()

  • 4.52 in L
G207153

  • Surgical instrument torque limiter
Integra® Ti6® The TS-series drill guide is used for precision and accuracy when drilling 3.0 and 4.0mm screws.
Ascension Orthopedics, Inc.
FS2060
In Commercial Distribution

  • M269FS20601 ()
  • 10381780245056 ()

  • 3.516 in L
FS2060

  • Surgical drill guide, reusable
Integra® Ti6® The TS-series drill guide is used for precision and accuracy when drilling 2.0 and 2.5mm screws.
Ascension Orthopedics, Inc.
FS2050
In Commercial Distribution

  • M269FS20501 ()
  • 10381780245049 ()

  • 3.074 in L
FS2050

  • Surgical drill guide, reusable
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