The following data is part of a premarket notification filed by Luitpold Pharmaceuticals, Inc. with the FDA for Osteo-pin Membrane Fixation Pin.
| Device ID | K990537 |
| 510k Number | K990537 |
| Device Name: | OSTEO-PIN MEMBRANE FIXATION PIN |
| Classification | Bone Grafting Material, Synthetic |
| Applicant | LUITPOLD PHARMACEUTICALS, INC. 1050 CONNECTICUT AVENUE, N.W. Washington, DC 20036 -5339 |
| Contact | Peter S Reichertz |
| Correspondent | Peter S Reichertz LUITPOLD PHARMACEUTICALS, INC. 1050 CONNECTICUT AVENUE, N.W. Washington, DC 20036 -5339 |
| Product Code | LYC |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-02-19 |
| Decision Date | 1999-11-19 |