The following data is part of a premarket notification filed by K2m, Inc. with the FDA for Cayman Buttress Plate System.
| Device ID | K080302 |
| 510k Number | K080302 |
| Device Name: | CAYMAN BUTTRESS PLATE SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | K2M, INC. 751 MILLER DR.,SE Leesburg, VA 20175 |
| Contact | Richard Woods |
| Correspondent | Richard Woods K2M, INC. 751 MILLER DR.,SE Leesburg, VA 20175 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-02-05 |
| Decision Date | 2008-03-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10888857020085 | K080302 | 000 |
| 10888857018587 | K080302 | 000 |
| 10888857018594 | K080302 | 000 |
| 10888857018600 | K080302 | 000 |
| 10888857018617 | K080302 | 000 |
| 10888857018624 | K080302 | 000 |
| 10888857020030 | K080302 | 000 |
| 10888857020047 | K080302 | 000 |
| 10888857020054 | K080302 | 000 |
| 10888857018570 | K080302 | 000 |