| Primary Device ID | 00850072364070 |
| NIH Device Record Key | dbe00dec-93de-4ddb-9418-45e469826336 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BOLT, Ti6Al4V, 7.0mm x 160-180mm, 5mm HEX |
| Version Model Number | 104-0156-05 |
| Company DUNS | 133439875 |
| Company Name | ORTHO OUTCOMES, 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 | true |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850072364070 [Primary] |
| HWC | Screw, Fixation, Bone |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00850072364070]
Moist Heat or Steam Sterilization
[00850072364070]
Moist Heat or Steam Sterilization
[00850072364070]
Moist Heat or Steam Sterilization
[00850072364070]
Moist Heat or Steam Sterilization
[00850072364070]
Moist Heat or Steam Sterilization
[00850072364070]
Moist Heat or Steam Sterilization
[00850072364070]
Moist Heat or Steam Sterilization
[00850072364070]
Moist Heat or Steam Sterilization
[00850072364070]
Moist Heat or Steam Sterilization
[00850072364070]
Moist Heat or Steam Sterilization
[00850072364070]
Moist Heat or Steam Sterilization
[00850072364070]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-03-09 |
| Device Publish Date | 2026-02-28 |
| 00850072364032 - BOLT, Ti6Al4V, 7.0mm x 80-100mm, 5mm HEX | 2026-03-09 BOLT, Ti6Al4V, 7.0mm x 80-100mm, 5mm HEX |
| 00850072364049 - BOLT, Ti6Al4V, 7.0mm x 100-120mm, 5mm HEX | 2026-03-09 BOLT, Ti6Al4V, 7.0mm x 100-120mm, 5mm HEX |
| 00850072364056 - BOLT, Ti6Al4V, 7.0mm x 120-140mm, 5mm HEX | 2026-03-09 BOLT, Ti6Al4V, 7.0mm x 120-140mm, 5mm HEX |
| 00850072364063 - BOLT, Ti6Al4V, 7.0mm x 140-160mm, 5mm HEX | 2026-03-09 BOLT, Ti6Al4V, 7.0mm x 140-160mm, 5mm HEX |
| 00850072364070 - BOLT, Ti6Al4V, 7.0mm x 160-180mm, 5mm HEX | 2026-03-09BOLT, Ti6Al4V, 7.0mm x 160-180mm, 5mm HEX |
| 00850072364070 - BOLT, Ti6Al4V, 7.0mm x 160-180mm, 5mm HEX | 2026-03-09 BOLT, Ti6Al4V, 7.0mm x 160-180mm, 5mm HEX |
| 00850072364087 - NUT SLEEVE, Ti6Al4V, 7.0mm x 80-100mm, 5mm HEX | 2026-03-09 NUT SLEEVE, Ti6Al4V, 7.0mm x 80-100mm, 5mm HEX |
| 00850072364094 - NUT SLEEVE, Ti6Al4V, 7.0mm x 100-120mm, 5mm HEX | 2026-03-09 NUT SLEEVE, Ti6Al4V, 7.0mm x 100-120mm, 5mm HEX |
| 00850072364100 - NUT SLEEVE, Ti6Al4V, 7.0mm x 120-140mm, 5mm HEX | 2026-03-09 NUT SLEEVE, Ti6Al4V, 7.0mm x 120-140mm, 5mm HEX |