Fiji Anchor
Fastener, Fixation, Biodegradable, Soft Tissue
SportWelding GmbH
The following data is part of a premarket notification filed by Sportwelding Gmbh with the FDA for Fiji Anchor.
Pre-market Notification Details
| Device ID | K171228 |
| 510k Number | K171228 |
| Device Name: | Fiji Anchor |
| Classification | Fastener, Fixation, Biodegradable, Soft Tissue |
| Applicant | SportWelding GmbH Wagistrasse 6 Schlieren, CH 8952 |
| Contact | Joerg Mayer |
| Correspondent | Janice M. Hogan Hogan Lovells US LLP 1835 Market Street, 29th Floor Philadelphia, PA 19103 |
| Product Code | MAI |
| Subsequent Product Code | GAT |
| Subsequent Product Code | HTY |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-04-26 |
| Decision Date | 2018-01-19 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07649990202167 | K171228 | 000 |
| 07649990202181 | K171228 | 000 |
| 07649990202204 | K171228 | 000 |
| 07649990202082 | K171228 | 000 |
| 07649990202358 | K171228 | 000 |
| 07649990202013 | K171228 | 000 |
| 07649990202037 | K171228 | 000 |
| 07649990202044 | K171228 | 000 |
| 07649990202051 | K171228 | 000 |
| 07649990202143 | K171228 | 000 |
| 07649990202150 | K171228 | 000 |
| 07649990202020 | K171228 | 000 |
Trademark Results [Fiji Anchor]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FIJI ANCHOR 79104194 4244020 Live/Registered |
SportWelding GmbH 2011-09-20 |
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