The following data is part of a premarket notification filed by Precision Surgery Ltd. with the FDA for Fixed Variable & Corpectomy Cervical Plate System.
| Device ID | K103838 |
| 510k Number | K103838 |
| Device Name: | FIXED VARIABLE & CORPECTOMY CERVICAL PLATE SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | PRECISION SURGERY LTD. 8202 SHERMAN ROAD Chesterland, OH 44026 -2141 |
| Contact | Karen E Warden, Phd. |
| Correspondent | Karen E Warden, Phd. PRECISION SURGERY LTD. 8202 SHERMAN ROAD Chesterland, OH 44026 -2141 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-30 |
| Decision Date | 2011-02-15 |
| Summary: | summary |