The following data is part of a premarket notification filed by Spectrum Spine, Llc with the FDA for Spectrum Spine Fenestrated Facet Screw System.
| Device ID | K132126 |
| 510k Number | K132126 |
| Device Name: | SPECTRUM SPINE FENESTRATED FACET SCREW SYSTEM |
| Classification | System, Facet Screw Spinal Device |
| Applicant | SPECTRUM SPINE, LLC 100 E. SOUTH MAIN ST. P.O. BOX 1458 Waxhaw, NC 28173 |
| Contact | Ottie Pendleton |
| Correspondent | Ottie Pendleton SPECTRUM SPINE, LLC 100 E. SOUTH MAIN ST. P.O. BOX 1458 Waxhaw, NC 28173 |
| Product Code | MRW |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-10 |
| Decision Date | 2013-10-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842166180789 | K132126 | 000 |
| 00842166121539 | K132126 | 000 |
| 00842166121522 | K132126 | 000 |
| 00842166121515 | K132126 | 000 |
| 00842166121508 | K132126 | 000 |
| 00842166121492 | K132126 | 000 |
| 00842166116450 | K132126 | 000 |
| 00842166185296 | K132126 | 000 |
| 00842166185289 | K132126 | 000 |
| 00842166188945 | K132126 | 000 |
| 00842166180673 | K132126 | 000 |
| 00842166180680 | K132126 | 000 |
| 00842166180772 | K132126 | 000 |
| 00842166180765 | K132126 | 000 |
| 00842166180758 | K132126 | 000 |
| 00842166180741 | K132126 | 000 |
| 00842166180734 | K132126 | 000 |
| 00842166180727 | K132126 | 000 |
| 00842166180710 | K132126 | 000 |
| 00842166180703 | K132126 | 000 |
| 00842166180697 | K132126 | 000 |
| 00842166192263 | K132126 | 000 |