The following data is part of a premarket notification filed by Advanced Surgical Implants, Inc. with the FDA for Ogden Anchor.
| Device ID | K924367 |
| 510k Number | K924367 |
| Device Name: | OGDEN ANCHOR |
| Classification | Staple, Fixation, Bone |
| Applicant | ADVANCED SURGICAL IMPLANTS, INC. 7410 CROSS COUNTY RD., STE. E North Charleston, SC 29418 |
| Contact | Bruce F Meadows |
| Correspondent | Bruce F Meadows ADVANCED SURGICAL IMPLANTS, INC. 7410 CROSS COUNTY RD., STE. E North Charleston, SC 29418 |
| Product Code | JDR |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-28 |
| Decision Date | 1993-07-26 |