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 |