The following data is part of a premarket notification filed by Sgarlato Laboratories, Inc. with the FDA for Threaded Fixation Pin.
| Device ID | K982931 |
| 510k Number | K982931 |
| Device Name: | THREADED FIXATION PIN |
| Classification | Pin, Fixation, Threaded |
| Applicant | SGARLATO LABORATORIES, INC. 250 ALMENDRA AVE. Los Gatos, CA 95030 |
| Contact | Thomas Sgarlato |
| Correspondent | Thomas Sgarlato SGARLATO LABORATORIES, INC. 250 ALMENDRA AVE. Los Gatos, CA 95030 |
| Product Code | JDW |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-08-20 |
| Decision Date | 1998-10-21 |
| Summary: | summary |