The following data is part of a premarket notification filed by Providence Medical Technology, Inc. with the FDA for Ally(tm) Bone Screws.
| Device ID | K170698 |
| 510k Number | K170698 |
| Device Name: | ALLY(TM) Bone Screws |
| Classification | Screw, Fixation, Bone |
| Applicant | Providence Medical Technology, Inc. 1331 N. California Blvd., Suite 320 Walnut Creek, CA 94596 |
| Contact | Margaret Wong |
| Correspondent | Edward Liou Providence Medical Technology, Inc. 1331 N. California Blvd., Suite 320 Walnut Creek, CA 94596 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-07 |
| Decision Date | 2017-05-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00852776006553 | K170698 | 000 |