The following data is part of a premarket notification filed by Karlin Technology, Inc. with the FDA for Bone Screw.
| Device ID | K893203 |
| 510k Number | K893203 |
| Device Name: | BONE SCREW |
| Classification | Staple, Fixation, Bone |
| Applicant | KARLIN TECHNOLOGY, INC. 2730 MONTEREY ST, #104 Torrance, CA 90503 |
| Contact | Mark J Weidhaas |
| Correspondent | Mark J Weidhaas KARLIN TECHNOLOGY, INC. 2730 MONTEREY ST, #104 Torrance, CA 90503 |
| Product Code | JDR |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-26 |
| Decision Date | 1990-04-04 |