The following data is part of a premarket notification filed by Providence Medical Technology, Inc. with the FDA for Pmt Bone Screws.
| Device ID | K121713 |
| 510k Number | K121713 |
| Device Name: | PMT BONE SCREWS |
| Classification | Screw, Fixation, Bone |
| Applicant | PROVIDENCE MEDICAL TECHNOLOGY, INC. 3650 MT Diablo Blvd Ste 104 Lafayette, CA 94549 |
| Contact | Glen Mangseth |
| Correspondent | Glen Mangseth PROVIDENCE MEDICAL TECHNOLOGY, INC. 3650 MT Diablo Blvd Ste 104 Lafayette, CA 94549 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-06-11 |
| Decision Date | 2012-09-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10852776006314 | K121713 | 000 |
| 10852776006307 | K121713 | 000 |
| 00852776006027 | K121713 | 000 |
| 10852776006024 | K121713 | 000 |
| 20852776006024 | K121713 | 000 |
| 20852776006021 | K121713 | 000 |