| Primary Device ID | 00860013905958 |
| NIH Device Record Key | 0c733c9c-8b06-410d-87f5-69c779cce4d9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Integrity Orthopaedics |
| Version Model Number | 901001 |
| Catalog Number | 901001 |
| Company DUNS | 118804591 |
| Company Name | Integrity Orthopaedics, Inc |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| 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 | true |
| 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 | 00860013905958 [Primary] |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-05-26 |
| Device Publish Date | 2025-05-16 |
| 00860009782228 | Integrity Orthopaedics Anchor Array System Kit |
| 00860009782211 | Integrity Orthopaedics Delivery Instrument, included with Anchor Array System Kit |
| 00860013905989 | Tendon Seam™ Magazine - 4 Anchor |
| 00860013905972 | Tendon Seam™ Instrument Kit - 4 Anchor |
| 00860013905965 | Delivery Instrument, included with Tendon Seam™ Instrument Kit - 4 Anchor |
| 00860013905958 | Tendon Seam™ Magazine - 4 Anchor, included with Tendon Seam™ Instrument Kit - 4 Anchor |
| 00860013905941 | Tendon Seam™ Magazine - 8 Anchor |
| 00860013905934 | Tendon Seam™ Instrument Kit - 8 Anchor |
| 00860013905927 | Delivery Instrument, included with Tendon Seam™ Instrument Kit - 8 Anchor |
| 00860013905910 | Tendon Seam™ Magazine - 8 Anchor, included with Tendon Seam™ Instrument Kit - 8 Anchor |