| Primary Device ID | 00819917028348 |
| NIH Device Record Key | d2732f65-0ca2-4ed0-a30b-26d7ac288d3e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Foot Osteotomy Wedge System |
| Version Model Number | 03.844.208 |
| Catalog Number | 03.844.208 |
| Company DUNS | 010968002 |
| Company Name | Tyber Medical LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| 00819917028379 | Evans Osteotomy Trial, 22mm x 12mm |
| 00819917028362 | Evans Osteotomy Trial, 20mm x 12mm |
| 00819917028355 | Evans Osteotomy Trial, 20mm x 10mm |
| 00819917028348 | Evans Osteotomy Trial, 20mm x 8mm |
| 00819917028331 | Cotton Osteotomy Trial, 20mm x 6.5mm |
| 00819917028324 | Cotton Osteotomy Trial, 20mm x 5.5mm |
| 00819917028317 | Cotton Osteotomy Trial, 20mm x 4.5mm |
| 00819917028300 | Ø2.4mm Pin (6") |
| 00819917028294 | Straight Rod Inserter |
| 00819917028249 | Evans Osteotomy Trial, 18mm x 8mm |
| 00819917028232 | Evans Osteotomy Trial, 18mm x 10mm |
| 00819917028225 | Cotton Osteotomy Trial, 16mm x 5.5mm |
| 00819917028195 | Cotton Osteotomy Trial, 16mm x 4.5mm |
| 00819917021875 | Evans Osteotomy Trial, 22mm x 10mm |
| 00819917028270 | Hintermann Distractor |
| 00819917028263 | “V” Tamp 6” |
| M695GTPC14955S0 | ACIF TyPEEK 14mm x 9mm x 5 deg Straight |
| M695GTPC14855S0 | ACIF TyPEEK 14mm x 8mm x 5 deg Straight |
| M695GTPC14755S0 | ACIF TyPEEK 14mm x 7mm x 5 deg Straight |
| M695GTPC14655S0 | ACIF TyPEEK 14mm x 6mm x 5 deg Straight |
| M695GTPC14555S0 | ACIF TyPEEK 14mm x 5mm x 5 deg Straight |
| M695GTPC141255S0 | ACIF TyPEEK 14mm x 12mm x 5 deg Straight |
| M695GTPC141155S0 | ACIF TyPEEK 14mm x 11mm x 5 deg Straight |
| M695GTPC141055S0 | ACIF TyPEEK 14mm x 10mm x 5 deg Straight |
| M6951407120 | CerviFuse Lordotic Spacer, 11 x 14 x 12mm |
| M6951407110 | CerviFuse Lordotic Spacer, 11 x 14 x 11mm |
| M6951407100 | CerviFuse Lordotic Spacer, 11 x 14 x 10mm |
| M6951407090 | CerviFuse Lordotic Spacer, 11 x 14 x 9mm |
| M6951407080 | CerviFuse Lordotic Spacer, 11 x 14 x 8mm |
| M6951407070 | CerviFuse Lordotic Spacer, 11 x 14 x 7mm |
| M6951407060 | CerviFuse Lordotic Spacer, 11 x 14 x 6mm |
| M6951407050 | CerviFuse Lordotic Spacer, 11 x 14 x 5mm |
| 00819917028386 | Wedge Instrument Graphic Case |
| 00819917028218 | Cotton Osteotomy Trial, 16mm x 6.5mm |
| 00819917028201 | Cotton Osteotomy Trial, 16mm x 5.5mm |
| 00819917028287 | Evans Osteotomy Trial, 18mm x 12mm |
| 00819917028188 | 08.844.312S |
| 00819917028171 | 08.844.310S |
| 00819917028164 | 08.844.308S |
| 00819917028157 | 08.844.212S |
| 00819917028140 | 08.844.210S |
| 00819917028133 | 08.844.208S |
| 00819917028126 | 08.844.206S |
| 00819917028119 | 08.844.205S |
| 00819917028102 | 08.844.204S |
| 00819917028096 | 08.844.112S |
| 00819917028089 | 08.844.110S |
| 00819917028072 | 08.844.108S |
| 00819917028065 | 08.844.106S |
| 00819917028058 | 08.844.105S |