The following data is part of a premarket notification filed by Choice Spine, Lp with the FDA for Raven Lumbar Plate System.
| Device ID | K183214 |
| 510k Number | K183214 |
| Device Name: | Raven Lumbar Plate System |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | Choice Spine, LP 400 Erin Drive Knoxville, TN 37919 |
| Contact | Kim Finch |
| Correspondent | Kim Finch Choice Spine, LP 400 Erin Drive Knoxville, TN 37919 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-19 |
| Decision Date | 2019-01-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840996177153 | K183214 | 000 |
| 00840996176897 | K183214 | 000 |
| 00840996176903 | K183214 | 000 |
| 00840996176910 | K183214 | 000 |
| 00840996176927 | K183214 | 000 |
| 00840996176934 | K183214 | 000 |
| 00840996176941 | K183214 | 000 |
| 00840996176958 | K183214 | 000 |
| 00840996176965 | K183214 | 000 |
| 00840996176972 | K183214 | 000 |
| 00840996176996 | K183214 | 000 |
| 00840996177085 | K183214 | 000 |
| 00840996177092 | K183214 | 000 |
| 00840996177108 | K183214 | 000 |
| 00840996177115 | K183214 | 000 |
| 00840996177122 | K183214 | 000 |
| 00840996177139 | K183214 | 000 |
| 00840996177146 | K183214 | 000 |
| 00840996176880 | K183214 | 000 |