The following data is part of a premarket notification filed by Karlin Technology, Inc. with the FDA for Spinal Microknife.
| Device ID | K882525 |
| 510k Number | K882525 |
| Device Name: | SPINAL MICROKNIFE |
| Classification | Knife, Orthopedic |
| Applicant | KARLIN TECHNOLOGY, INC. 330 WASHINGTON ST. SUITE 314 Marina Del Rey, CA 90292 |
| Contact | Mark Weidhaas |
| Correspondent | Mark Weidhaas KARLIN TECHNOLOGY, INC. 330 WASHINGTON ST. SUITE 314 Marina Del Rey, CA 90292 |
| Product Code | HTS |
| CFR Regulation Number | 888.4540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-06-17 |
| Decision Date | 1988-09-22 |