The following data is part of a premarket notification filed by K2m Inc. with the FDA for Ozark(tm) Cervical Plate System.
Device ID | K172104 |
510k Number | K172104 |
Device Name: | Ozark(tm) Cervical Plate System |
Classification | Appliance, Fixation, Spinal Intervertebral Body |
Applicant | K2M Inc. 600 Hope Pkwy. SE Leesburg, VA 20175 |
Contact | Nancy Giezen |
Correspondent | Karen E. Warden BackRoads Consulting, Inc PO Box 566 Chesterland, OH 44026 |
Product Code | KWQ |
CFR Regulation Number | 888.3060 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-07-12 |
Decision Date | 2017-08-23 |
Summary: | summary |