The following data is part of a premarket notification filed by K2m, Inc. with the FDA for Cayman Screws Model K2-12-1000-xx, K2-12-1001-xx.
| Device ID | K100061 |
| 510k Number | K100061 |
| Device Name: | CAYMAN SCREWS MODEL K2-12-1000-XX, K2-12-1001-XX |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | K2M, INC. 751 MILLER DR.,SE Leesburg, VA 20175 |
| Contact | Richard W Woods |
| Correspondent | Richard W Woods K2M, INC. 751 MILLER DR.,SE Leesburg, VA 20175 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-01-11 |
| Decision Date | 2010-02-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10888857018983 | K100061 | 000 |
| 10888857018976 | K100061 | 000 |
| 10888857018969 | K100061 | 000 |
| 10888857018778 | K100061 | 000 |
| 10888857018761 | K100061 | 000 |
| 10888857018754 | K100061 | 000 |