The following data is part of a premarket notification filed by Atlas Spine Inc. with the FDA for Atlas Spine Pivoting System.
| Device ID | K100743 |
| 510k Number | K100743 |
| Device Name: | ATLAS SPINE PIVOTING SYSTEM |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | ATLAS SPINE INC. 1555 JUPITER PARK DR., STE. 4 Jupiter, FL 33458 |
| Contact | Jeannette G Dailey |
| Correspondent | Jeannette G Dailey ATLAS SPINE INC. 1555 JUPITER PARK DR., STE. 4 Jupiter, FL 33458 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-03-16 |
| Decision Date | 2010-08-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10840642107890 | K100743 | 000 |
| 10840642107609 | K100743 | 000 |
| 10840642107593 | K100743 | 000 |
| 10840642107586 | K100743 | 000 |
| 10840642107579 | K100743 | 000 |
| 10840642107562 | K100743 | 000 |
| 10840642107555 | K100743 | 000 |
| 10840642107548 | K100743 | 000 |
| 10840642107531 | K100743 | 000 |
| 10840642107524 | K100743 | 000 |
| 10840642107517 | K100743 | 000 |
| 10840642107500 | K100743 | 000 |
| 10840642107616 | K100743 | 000 |
| 10840642107623 | K100743 | 000 |
| 10840642107883 | K100743 | 000 |
| 10840642107722 | K100743 | 000 |
| 10840642107715 | K100743 | 000 |
| 10840642107708 | K100743 | 000 |
| 10840642107692 | K100743 | 000 |
| 10840642107685 | K100743 | 000 |
| 10840642107678 | K100743 | 000 |
| 10840642107661 | K100743 | 000 |
| 10840642107654 | K100743 | 000 |
| 10840642107647 | K100743 | 000 |
| 10840642107630 | K100743 | 000 |
| 10840642107494 | K100743 | 000 |