The following data is part of a premarket notification filed by Coalign Innovations, Inc. with the FDA for Acculif Tl And Pl Cage.
| Device ID | K132505 |
| 510k Number | K132505 |
| Device Name: | ACCULIF TL AND PL CAGE |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | COALIGN INNOVATIONS, INC. 1331 H STREET NW 12TH FLOOR Washington, DC 20005 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-12 |
| Decision Date | 2013-09-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327067118 | K132505 | 000 |
| 07613327067101 | K132505 | 000 |
| 37613327067096 | K132505 | 000 |
| 37613327067089 | K132505 | 000 |
| 07613327067071 | K132505 | 000 |
| 07613327067064 | K132505 | 000 |
| 07613327066753 | K132505 | 000 |