The following data is part of a premarket notification filed by Providence Medical Technology, Inc. with the FDA for Pmt Posterior Fixation System.
Device ID | K172279 |
510k Number | K172279 |
Device Name: | PMT Posterior Fixation System |
Classification | Posterior Cervical Screw System |
Applicant | Providence Medical Technology, Inc. 1331 N. California Blvd. Suite 320 Walnut Creek, CA 94596 |
Contact | Edward Liou |
Correspondent | Edward Liou Providence Medical Technology, Inc. 1331 North California Boulevard, Suite 320 Walnut Creek, CA 94596 |
Product Code | NKG |
CFR Regulation Number | 888.3075 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-07-28 |
Decision Date | 2017-09-20 |
Summary: | summary |