The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Luque Segmental Spinal Instrumentation.
| Device ID | K913561 |
| 510k Number | K913561 |
| Device Name: | LUQUE SEGMENTAL SPINAL INSTRUMENTATION |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Contact | Henry Quello |
| Correspondent | Henry Quello ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Product Code | KWP |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-09 |
| Decision Date | 1992-01-16 |