The following data is part of a premarket notification filed by Codman & Shurtleff, Inc. with the FDA for Codman Craniosorb Absorbable Fixation System Purple Rivets.
| Device ID | K003549 |
| 510k Number | K003549 |
| Device Name: | CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM PURPLE RIVETS |
| Classification | Plate, Bone |
| Applicant | Codman & Shurtleff, Inc. 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
| Contact | James M Flaherty |
| Correspondent | James M Flaherty Codman & Shurtleff, Inc. 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-11-17 |
| Decision Date | 2001-02-15 |