The following data is part of a premarket notification filed by Acuitive Technologies with the FDA for Citregen Tendon Interference Screw And Citrelock.
| Device ID | K200725 |
| 510k Number | K200725 |
| Device Name: | Citregen Tendon Interference Screw And Citrelock |
| Classification | Fastener, Fixation, Biodegradable, Soft Tissue |
| Applicant | Acuitive Technologies 50 Commerce Drive Allendale, NJ 07401 |
| Contact | Jaclyn Docs |
| Correspondent | Janice Hogan Hogan Lovells US. LLP 1735 Market Street Philadelphia, PA 19103 |
| Product Code | MAI |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-19 |
| Decision Date | 2020-10-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810027270269 | K200725 | 000 |
| 00810027270139 | K200725 | 000 |
| 00810027270122 | K200725 | 000 |
| 00810027270115 | K200725 | 000 |
| 00810027270108 | K200725 | 000 |
| 00810027270092 | K200725 | 000 |
| 00810027270085 | K200725 | 000 |
| 00810027270078 | K200725 | 000 |
| 00810027270061 | K200725 | 000 |
| 00810027270054 | K200725 | 000 |
| 00810027270047 | K200725 | 000 |
| 00810027270030 | K200725 | 000 |
| 00810027270023 | K200725 | 000 |
| 00810027270016 | K200725 | 000 |
| 00810027270009 | K200725 | 000 |
| 00810027270160 | K200725 | 000 |
| 00810027270153 | K200725 | 000 |
| 00810027270177 | K200725 | 000 |
| 00810027270283 | K200725 | 000 |
| 00810027270252 | K200725 | 000 |
| 00810027270245 | K200725 | 000 |
| 00810027270238 | K200725 | 000 |
| 00810027270221 | K200725 | 000 |
| 00810027270214 | K200725 | 000 |
| 00810027270207 | K200725 | 000 |
| 00810027270191 | K200725 | 000 |
| 00810027270184 | K200725 | 000 |
| 00810027270375 | K200725 | 000 |
| 00810027270368 | K200725 | 000 |
| 00810027270351 | K200725 | 000 |
| 00810027270344 | K200725 | 000 |
| 00810027270337 | K200725 | 000 |
| 00810027270320 | K200725 | 000 |
| 00810027270313 | K200725 | 000 |
| 00810027270290 | K200725 | 000 |
| 00810027270146 | K200725 | 000 |