The following data is part of a premarket notification filed by Summit Medical Ltd. with the FDA for Anchorman Tibial Ligament Fixation Device.
| Device ID | K170388 |
| 510k Number | K170388 |
| Device Name: | ANCHORMAN Tibial Ligament Fixation Device |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | Summit Medical Ltd. Bourton Industrial Park Bourton On The Water, GB Gl54 2hq |
| Contact | Sam Drew |
| Correspondent | Sam Drew Summit Medical Ltd. Bourton Industrial Park Bourton On The Water, GB Gl54 2hq |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-02-08 |
| Decision Date | 2017-07-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15060238200971 | K170388 | 000 |