The following data is part of a premarket notification filed by Precision Spine, Inc. with the FDA for Accufit Lateral 2-hole Plate.
| Device ID | K220324 |
| 510k Number | K220324 |
| Device Name: | AccuFit Lateral 2-Hole Plate |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | Precision Spine, Inc. 2050 Executive Drive Pearl, MS 39208 |
| Contact | Michael Dawson |
| Correspondent | Lisa Ferrara Element Materials Technology 3701 Port Union Road Farfield, OH 45014 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-02-03 |
| Decision Date | 2022-03-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840019965910 | K220324 | 000 |
| 00840019965903 | K220324 | 000 |
| 00840019965897 | K220324 | 000 |
| 00840019965859 | K220324 | 000 |
| 00840019965842 | K220324 | 000 |
| 00840019965835 | K220324 | 000 |
| 00840019965828 | K220324 | 000 |
| 00840019965811 | K220324 | 000 |