The following data is part of a premarket notification filed by Oc Medical Devices with the FDA for Focus Interbody System.
| Device ID | K221172 |
| 510k Number | K221172 |
| Device Name: | FOCUS Interbody System |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | OC Medical Devices 15 East Montgomery Crossroads, Suite 3 Savannah, GA 31406 |
| Contact | Jack Mathews |
| Correspondent | Karen E. Warden BackRoads Consulting Inc. P.O. Box 566 Chesterland, OH 44026 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-04-25 |
| Decision Date | 2022-10-14 |