The following data is part of a premarket notification filed by Atlas Spine Inc. with the FDA for Atlas Spine Spacer.
| Device ID | K081880 |
| 510k Number | K081880 |
| Device Name: | ATLAS SPINE SPACER |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| 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 | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-07-02 |
| Decision Date | 2008-10-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M681SCC0020140 | K081880 | 000 |
| M681SCC0010130 | K081880 | 000 |
| M681SCC0010120 | K081880 | 000 |
| M681SCC0010111 | K081880 | 000 |
| M681SCC0010100 | K081880 | 000 |
| M681SCC0010090 | K081880 | 000 |
| M681SCC0010080 | K081880 | 000 |
| M681SCC0010070 | K081880 | 000 |
| M681SCC0010060 | K081880 | 000 |
| M681SCC0010140 | K081880 | 000 |
| M681SCC0020050 | K081880 | 000 |
| M681SCC0020130 | K081880 | 000 |
| M681SCC0020120 | K081880 | 000 |
| M681SCC0020110 | K081880 | 000 |
| M681SCC0020100 | K081880 | 000 |
| M681SCC0020090 | K081880 | 000 |
| M681SCC0020080 | K081880 | 000 |
| M681SCC0020070 | K081880 | 000 |
| M681SCC0020060 | K081880 | 000 |
| M681SCC0010050 | K081880 | 000 |