K913561 is an FDA 510(k) clearance for the LUQUE SEGMENTAL SPINAL INSTRUMENTATION. This device is classified as a Appliance, Fixation, Spinal Interlaminal (Class II - Special Controls, product code KWP).
Submitted by Zimmer, Inc. (Warsaw, US). The FDA issued a Cleared decision on January 16, 1992, 160 days after receiving the submission on August 9, 1991.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3050.
| 510(k) Number | K913561 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 09, 1991 |
| Decision Date | January 16, 1992 |
| Days to Decision | 160 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Statement |
| Product Code | KWP — Appliance, Fixation, Spinal Interlaminal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3050 |