The following data is part of a premarket notification filed by Spinal Usa with the FDA for Spinal Usa Anterior Lumbar Plate System.
| Device ID | K091044 |
| 510k Number | K091044 |
| Device Name: | SPINAL USA ANTERIOR LUMBAR PLATE SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | SPINAL USA 2050 EXECUTIVE DR. Pearl, MS 39208 |
| Contact | Jefferey Johnson |
| Correspondent | Jefferey Johnson SPINAL USA 2050 EXECUTIVE DR. Pearl, MS 39208 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-13 |
| Decision Date | 2009-07-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840019925587 | K091044 | 000 |
| 00840019912549 | K091044 | 000 |
| 00840019912532 | K091044 | 000 |
| 00840019912525 | K091044 | 000 |
| 00840019912518 | K091044 | 000 |
| 00840019912501 | K091044 | 000 |
| 00840019912495 | K091044 | 000 |
| 00840019912488 | K091044 | 000 |
| 00840019912471 | K091044 | 000 |
| 00840019912464 | K091044 | 000 |
| 00840019912556 | K091044 | 000 |
| 00840019912563 | K091044 | 000 |
| 00840019912570 | K091044 | 000 |
| 00840019912662 | K091044 | 000 |
| 00840019912655 | K091044 | 000 |
| 00840019912648 | K091044 | 000 |
| 00840019912631 | K091044 | 000 |
| 00840019912624 | K091044 | 000 |
| 00840019912617 | K091044 | 000 |
| 00840019912600 | K091044 | 000 |
| 00840019912594 | K091044 | 000 |
| 00840019912587 | K091044 | 000 |
| 00840019936910 | K091044 | 000 |