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 |