The following data is part of a premarket notification filed by Globus Medical, Inc. with the FDA for Sp-fix Spinous Process Fixation Plate.
| Device ID | K132191 |
| 510k Number | K132191 |
| Device Name: | SP-FIX SPINOUS PROCESS FIXATION PLATE |
| Classification | Spinous Process Plate |
| Applicant | GLOBUS MEDICAL, INC. 2560 GENERAL ARMISTEAD AVE. Audubon, PA 19403 |
| Contact | Christina Kichula |
| Correspondent | Christina Kichula GLOBUS MEDICAL, INC. 2560 GENERAL ARMISTEAD AVE. Audubon, PA 19403 |
| Product Code | PEK |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-15 |
| Decision Date | 2013-11-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00849044092639 | K132191 | 000 |
| 00849044091687 | K132191 | 000 |
| 00849044091786 | K132191 | 000 |
| 00849044091885 | K132191 | 000 |
| 00849044092080 | K132191 | 000 |
| 00849044092257 | K132191 | 000 |
| 00849044092356 | K132191 | 000 |
| 00849044092363 | K132191 | 000 |
| 00849044092370 | K132191 | 000 |
| 00849044092387 | K132191 | 000 |
| 00849044092394 | K132191 | 000 |
| 00849044092400 | K132191 | 000 |
| 00849044092417 | K132191 | 000 |
| 00849044092424 | K132191 | 000 |
| 00849044092431 | K132191 | 000 |
| 00849044092448 | K132191 | 000 |
| 00849044092547 | K132191 | 000 |
| 00849044092622 | K132191 | 000 |
| 00849044091588 | K132191 | 000 |