The following data is part of a premarket notification filed by Osteo Technology, Inc. with the FDA for Oti Orthopedic Fastener System.
| Device ID | K925301 |
| 510k Number | K925301 |
| Device Name: | OTI ORTHOPEDIC FASTENER SYSTEM |
| Classification | Pin, Fixation, Smooth |
| Applicant | OSTEO TECHNOLOGY, INC. 10 WEST AYLESBURY RD. Timonium, MD 21093 |
| Contact | Sam Son |
| Correspondent | Sam Son OSTEO TECHNOLOGY, INC. 10 WEST AYLESBURY RD. Timonium, MD 21093 |
| Product Code | HTY |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-10-21 |
| Decision Date | 1993-03-16 |