The following data is part of a premarket notification filed by Spinefrontier, Inc. with the FDA for Dorado Wide Intervertebral Body Cage, Models: Im2010-im2031.
| Device ID | K091638 |
| 510k Number | K091638 |
| Device Name: | DORADO WIDE INTERVERTEBRAL BODY CAGE, MODELS: IM2010-IM2031 |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | SPINEFRONTIER, INC. 500 CUMMINGS CENTER, STE. 3500 Beverly, MA 01915 |
| Contact | John Sullivan |
| Correspondent | John Sullivan SPINEFRONTIER, INC. 500 CUMMINGS CENTER, STE. 3500 Beverly, MA 01915 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-04 |
| Decision Date | 2009-09-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00190361006152 | K091638 | 000 |
| 00190361006145 | K091638 | 000 |