The following data is part of a premarket notification filed by K2m, Inc. with the FDA for Chesapeake Spinal System.
| Device ID | K092211 |
| 510k Number | K092211 |
| Device Name: | CHESAPEAKE SPINAL SYSTEM |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| 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 | OVD |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-22 |
| Decision Date | 2010-03-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10888857025424 | K092211 | 000 |
| 10888857025417 | K092211 | 000 |
| 10888857025400 | K092211 | 000 |