The following data is part of a premarket notification filed by American Medical Specialties, Inc. with the FDA for Steinman Pin.
| Device ID | K960483 |
| 510k Number | K960483 |
| Device Name: | STEINMAN PIN |
| Classification | Pin, Fixation, Smooth |
| Applicant | AMERICAN MEDICAL SPECIALTIES, INC. 6090-H MCDONOUGH DR. Norcross, GA 30093 |
| Contact | Roger Eaglen |
| Correspondent | Roger Eaglen AMERICAN MEDICAL SPECIALTIES, INC. 6090-H MCDONOUGH DR. Norcross, GA 30093 |
| Product Code | HTY |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-02-02 |
| Decision Date | 1996-04-09 |