The following data is part of a premarket notification filed by Tigon Medical with the FDA for Tigon Medical Tissue Anchors.
| Device ID | K182507 |
| 510k Number | K182507 |
| Device Name: | Tigon Medical Tissue Anchors |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | Tigon Medical 517 Benfield Rd Severna Park, MD 21146 |
| Contact | Jeremy Clark |
| Correspondent | Lee Strnad Intrepid Orthopedics, LLC 3953 Humphrey Rd Richfield, OH 44286 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-12 |
| Decision Date | 2019-01-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00867430000457 | K182507 | 000 |
| 00850029805656 | K182507 | 000 |
| 00867430000402 | K182507 | 000 |
| 00867430000440 | K182507 | 000 |
| 00867430000471 | K182507 | 000 |
| 00854288008025 | K182507 | 000 |
| 00854288008063 | K182507 | 000 |
| 00854288008087 | K182507 | 000 |
| 00867430000426 | K182507 | 000 |
| 00850029805373 | K182507 | 000 |