The following data is part of a premarket notification filed by Precision Spine, Inc. with the FDA for Accufit Lateral Plate System.
| Device ID | K162211 |
| 510k Number | K162211 |
| Device Name: | AccuFit Lateral Plate System |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | PRECISION SPINE, INC. 5 SYLVAN WAY SUITE 220 Parsippany, NJ 07930 |
| Contact | Michael C. Dawson |
| Correspondent | Kenneth C. Maxwell EMPIRICAL TESTING CORP. 4628 NORTHPARK DRIVE Colorado Springs, CO 80918 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-08 |
| Decision Date | 2016-11-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840019919876 | K162211 | 000 |
| 00840019904513 | K162211 | 000 |
| 00840019904506 | K162211 | 000 |
| 00840019904490 | K162211 | 000 |
| 00840019904483 | K162211 | 000 |
| 00840019904476 | K162211 | 000 |
| 00840019904469 | K162211 | 000 |
| 00840019904452 | K162211 | 000 |
| 00815362025147 | K162211 | 000 |
| 00815362023334 | K162211 | 000 |
| 00840019936491 | K162211 | 000 |
| 00840019967457 | K162211 | 000 |
| 00840019904520 | K162211 | 000 |
| 00840019904537 | K162211 | 000 |
| 00840019904643 | K162211 | 000 |
| 00840019904636 | K162211 | 000 |
| 00840019904629 | K162211 | 000 |
| 00840019904612 | K162211 | 000 |
| 00840019904605 | K162211 | 000 |
| 00840019904599 | K162211 | 000 |
| 00840019904582 | K162211 | 000 |
| 00840019904575 | K162211 | 000 |
| 00840019904568 | K162211 | 000 |
| 00840019904551 | K162211 | 000 |
| 00840019904544 | K162211 | 000 |
| 00840019967440 | K162211 | 000 |