The following data is part of a premarket notification filed by Spinal Usa with the FDA for Spinal Usa Rcs Anterior Lumbar Butress Plate System, Model 22-1001-25.
| Device ID | K092659 |
| 510k Number | K092659 |
| Device Name: | SPINAL USA RCS ANTERIOR LUMBAR BUTRESS PLATE SYSTEM, MODEL 22-1001-25 |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | SPINAL USA 2050 EXECUTIVE DR. Pearl, MS 39208 |
| Contact | Jeffrey Johnson |
| Correspondent | Jeffrey Johnson SPINAL USA 2050 EXECUTIVE DR. Pearl, MS 39208 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-08-28 |
| Decision Date | 2009-11-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815362021071 | K092659 | 000 |
| 00815362021026 | K092659 | 000 |
| 00815362021019 | K092659 | 000 |
| 00815362021002 | K092659 | 000 |
| 00815362020999 | K092659 | 000 |
| 00815362020982 | K092659 | 000 |
| 00815362020975 | K092659 | 000 |
| 00840019936224 | K092659 | 000 |