| Primary Device ID | 00841506130316 |
| NIH Device Record Key | 73dfeee8-3e6f-43cc-bc56-1786ff667451 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Humeral Fixation Set |
| Version Model Number | Screw, FreeFix™ Compression, 3.5mm x 18mm, Ti |
| Catalog Number | FFC-35180-TS |
| Company DUNS | 869056148 |
| Company Name | SKELETAL DYNAMICS L.L.C. |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841506130316 [Primary] |
| HRS | Plate, fixation, bone |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00841506130316]
Moist Heat or Steam Sterilization
[00841506130316]
Moist Heat or Steam Sterilization
[00841506130316]
Moist Heat or Steam Sterilization
[00841506130316]
Moist Heat or Steam Sterilization
[00841506130316]
Moist Heat or Steam Sterilization
[00841506130316]
Moist Heat or Steam Sterilization
[00841506130316]
Moist Heat or Steam Sterilization
[00841506130316]
Moist Heat or Steam Sterilization
[00841506130316]
Moist Heat or Steam Sterilization
[00841506130316]
Moist Heat or Steam Sterilization
[00841506130316]
Moist Heat or Steam Sterilization
[00841506130316]
Moist Heat or Steam Sterilization
[00841506130316]
Moist Heat or Steam Sterilization
[00841506130316]
Moist Heat or Steam Sterilization
[00841506130316]
Moist Heat or Steam Sterilization
[00841506130316]
Moist Heat or Steam Sterilization
[00841506130316]
Moist Heat or Steam Sterilization
[00841506130316]
Moist Heat or Steam Sterilization
[00841506130316]
Moist Heat or Steam Sterilization
[00841506130316]
Moist Heat or Steam Sterilization
[00841506130316]
Moist Heat or Steam Sterilization
[00841506130316]
Moist Heat or Steam Sterilization
[00841506130316]
Moist Heat or Steam Sterilization
[00841506130316]
Moist Heat or Steam Sterilization
[00841506130316]
Moist Heat or Steam Sterilization
[00841506130316]
Moist Heat or Steam Sterilization
[00841506130316]
Moist Heat or Steam Sterilization
[00841506130316]
Moist Heat or Steam Sterilization
[00841506130316]
Moist Heat or Steam Sterilization
[00841506130316]
Moist Heat or Steam Sterilization
[00841506130316]
Moist Heat or Steam Sterilization
[00841506130316]
Moist Heat or Steam Sterilization
[00841506130316]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-01-01 |
| Device Publish Date | 2023-12-22 |
| 00841506135205 | Tap, 4.5mm x 140mm |
| 00841506135199 | Tap, 3.5mm x 140mm |
| 00841506134888 | Humeral Fixation System B |
| 00841506134871 | Humeral Fixation System A |
| 00841506132525 | Humeral Fixation Set Tray B, Bottom Insert |
| 00841506132518 | Humeral Fixation Set Tray B, Middle Insert |
| 00841506132501 | Humeral Fixation Set Tray B, Top Insert |
| 00841506132495 | Humeral Fixation Set Tray B, Lid |
| 00841506132488 | Humeral Fixation Set Tray B, Base |
| 00841506132464 | Humeral Fixation Set Tray A, PROTEAN Screw Caddy |
| 00841506132457 | Humeral Fixation Set Tray A, Midshaft Humerus Scre |
| 00841506132440 | Humeral Fixation Set Tray A, Distal Humerus Screw |
| 00841506132433 | Humeral Fixation Set Tray A, Middle Insert |
| 00841506132426 | Humeral Fixation Set Tray A, Top Insert |
| 00841506132419 | Humeral Fixation Set Tray A, Lid |
| 00841506132402 | Humeral Fixation Set Tray A, Base |
| 00841506132396 | Humeral Fixation Set Tray A |
| 00841506132389 | Distal Humerus Plate, Supracondylar, 8 Hole, Left |
| 00841506132372 | Distal Humerus Plate, Supracondylar, 8 Hole, Right |
| 00841506132365 | Distal Humerus Plate, Supracondylar, 6 Hole, Left |
| 00841506132358 | Distal Humerus Plate, Supracondylar, 6 Hole, Right |
| 00841506132341 | Drill Guide, FreeFix™, HPS |
| 00841506131047 | K-Wire, Single Diamond Trocar, 1.5 mm x 229 mm |
| 00841506130699 | Drill, 3.5mm x 50mm, Reusable |
| 00841506130682 | Drill, 3.2mm x 50mm, Reusable |
| 00841506130675 | Drill, 2.0mm x 80mm, Reusable |
| 00841506130668 | Drill, Cannulated, 4.0mm x 20mm, Reusable |
| 00841506130651 | Drill, Cannulated, 3.7mm x 80mm, Reusable |
| 00841506130644 | Drill, 3.2mm / 4.5mm, Reusable |
| 00841506130637 | Countersink, 6.5mm, Reusable |
| 00841506130613 | Drill, Cannulated, PLS, 2.4mm x 40mm, Reusable |
| 00841506130446 | Screw, FreeFix™ Compression, 3.5mm x 44mm, Ti |
| 00841506130439 | Screw, FreeFix™ Compression, 3.5mm x 42mm, Ti |
| 00841506130422 | Screw, FreeFix™ Compression, 3.5mm x 40mm, Ti |
| 00841506130415 | Screw, FreeFix™ Compression, 3.5mm x 38mm, Ti |
| 00841506130408 | Screw, FreeFix™ Compression, 3.5mm x 36mm, Ti |
| 00841506130392 | Screw, FreeFix™ Compression, 3.5mm x 34mm, Ti |
| 00841506130385 | Screw, FreeFix™ Compression, 3.5mm x 32mm, Ti |
| 00841506130378 | Screw, FreeFix™ Compression, 3.5mm x 30mm, Ti |
| 00841506130361 | Screw, FreeFix™ Compression, 3.5mm x 28mm, Ti |
| 00841506130354 | Screw, FreeFix™ Compression, 3.5mm x 26mm, Ti |
| 00841506130347 | Screw, FreeFix™ Compression, 3.5mm x 24mm, Ti |
| 00841506130330 | Screw, FreeFix™ Compression, 3.5mm x 22mm, Ti |
| 00841506130323 | Screw, FreeFix™ Compression, 3.5mm x 20mm, Ti |
| 00841506130316 | Screw, FreeFix™ Compression, 3.5mm x 18mm, Ti |
| 00841506130293 | Screw, FreeFix™ Compression, 3.5mm x 16mm, Ti |
| 00841506130262 | Screw, FreeFix™ Compression, 3.5mm x 12mm, Ti |
| 00841506130248 | Screw, FreeFix™ Compression, 3.5mm x 10mm, Ti |
| 00841506130217 | Screw, FreeFix™ Locking, 3.5mm x 44mm, Ti |
| 00841506130200 | Screw, FreeFix™ Locking, 3.5mm x 42mm, Ti |