The following data is part of a premarket notification filed by Bioretec Ltd with the FDA for Bioretec Activascrew Interference.
| Device ID | K130716 |
| 510k Number | K130716 |
| Device Name: | BIORETEC ACTIVASCREW INTERFERENCE |
| Classification | Fastener, Fixation, Biodegradable, Soft Tissue |
| Applicant | BIORETEC LTD HERMIANKATU 22 MODULIGHT BLDG Tampere, FI Fi-33720 |
| Contact | Mari Ruotsalainen |
| Correspondent | Mari Ruotsalainen BIORETEC LTD HERMIANKATU 22 MODULIGHT BLDG Tampere, FI Fi-33720 |
| Product Code | MAI |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-15 |
| Decision Date | 2013-08-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E30210100904109 | K130716 | 000 |
| E30210100908289 | K130716 | 000 |
| E30210100908309 | K130716 | 000 |
| E30210100908339 | K130716 | 000 |
| E30210100909209 | K130716 | 000 |
| E30210100909249 | K130716 | 000 |
| E30210100909289 | K130716 | 000 |
| E30210100909309 | K130716 | 000 |
| E30210100909339 | K130716 | 000 |
| E30210100910249 | K130716 | 000 |
| E30210100910289 | K130716 | 000 |
| E30210100910309 | K130716 | 000 |
| E30210100908249 | K130716 | 000 |
| E30210100908209 | K130716 | 000 |
| E30210100907309 | K130716 | 000 |
| E30210100904159 | K130716 | 000 |
| E30210100904209 | K130716 | 000 |
| E30210100905109 | K130716 | 000 |
| E30210100905159 | K130716 | 000 |
| E30210100905209 | K130716 | 000 |
| E30210100906159 | K130716 | 000 |
| E30210100906209 | K130716 | 000 |
| E30210100906269 | K130716 | 000 |
| E30210100907209 | K130716 | 000 |
| E30210100907249 | K130716 | 000 |
| E30210100907269 | K130716 | 000 |
| E30210100910339 | K130716 | 000 |
| E302BAI04109 | K130716 | 000 |
| E302BAI08289 | K130716 | 000 |
| E302BAI08309 | K130716 | 000 |
| E302BAI08339 | K130716 | 000 |
| E302BAI09209 | K130716 | 000 |
| E302BAI09249 | K130716 | 000 |
| E302BAI09289 | K130716 | 000 |
| E302BAI09309 | K130716 | 000 |
| E302BAI09339 | K130716 | 000 |
| E302BAI10249 | K130716 | 000 |
| E302BAI10289 | K130716 | 000 |
| E302BAI10309 | K130716 | 000 |
| E302BAI08249 | K130716 | 000 |
| E302BAI08209 | K130716 | 000 |
| E302BAI07309 | K130716 | 000 |
| E302BAI04159 | K130716 | 000 |
| E302BAI04209 | K130716 | 000 |
| E302BAI05109 | K130716 | 000 |
| E302BAI05159 | K130716 | 000 |
| E302BAI05209 | K130716 | 000 |
| E302BAI06159 | K130716 | 000 |
| E302BAI06209 | K130716 | 000 |
| E302BAI06269 | K130716 | 000 |
| E302BAI07209 | K130716 | 000 |
| E302BAI07249 | K130716 | 000 |
| E302BAI07269 | K130716 | 000 |
| E302BAI10339 | K130716 | 000 |