| Primary Device ID | 00854501006173 |
| NIH Device Record Key | 018f2fa5-c30e-4cb5-bf39-0eaf8e692aa3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Bone Anchors with Arthroscopic Delivery System |
| Version Model Number | 2503-A |
| Catalog Number | 2503-A |
| Company DUNS | 031098401 |
| Company Name | ROTATION MEDICAL, INC. |
| 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 | true |
| 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 | 00854501006173 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-03-21 |
| Device Publish Date | 2018-01-09 |
| 00885556735657 - Bioinductive Implant with Arthroscopic Delivery System - Medium | 2019-08-28 |
| 00885556735664 - Bioinductive Implant with Arthroscopic Delivery System - Large | 2019-08-28 |
| 00854501006043 - Rotation Medical Arthroscopic Implant Set With Staples | 2019-03-21 |
| 00854501006074 - Rotation Medical Bone Staple Drivers With Staples | 2019-03-21 |
| 00854501006111 - Rotation Medical Bone Staple | 2019-03-21 |
| 00854501006159 - Bone Anchors with Arthroscopic Delivery System - Advanced | 2019-03-21 |
| 00854501006173 - Bone Anchors with Arthroscopic Delivery System | 2019-03-21 |
| 00854501006173 - Bone Anchors with Arthroscopic Delivery System | 2019-03-21 |
| 00854501006067 - Rotation Medical Tendon Staples | 2019-01-08 |