The following data is part of a premarket notification filed by United States Surgical, A Division Of Tyco Healthc with the FDA for Fixation Pin Or Rod.
| Device ID | K970036 |
| 510k Number | K970036 |
| Device Name: | FIXATION PIN OR ROD |
| Classification | Pin, Fixation, Smooth |
| Applicant | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
| Contact | Melissa Mazzoni |
| Correspondent | Melissa Mazzoni UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
| Product Code | HTY |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-03 |
| Decision Date | 1997-03-25 |
| Summary: | summary |