K901005 is an FDA 510(k) clearance for the TSRH SPINAL SYSTEM (ADD'L SIZES OF HOOKS). This device is classified as a Appliance, Fixation, Spinal Interlaminal (Class II - Special Controls, product code KWP).
Submitted by Danek Medical, Inc. (Memphis, US). The FDA issued a Cleared decision on December 10, 1990, 283 days after receiving the submission on March 2, 1990.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3050.
| 510(k) Number | K901005 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - NSE Converted (SN) |
| Date Received | March 02, 1990 |
| Decision Date | December 10, 1990 |
| Days to Decision | 283 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | — |
| Product Code | KWP — Appliance, Fixation, Spinal Interlaminal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3050 |