The following data is part of a premarket notification filed by Bioretec Ltd with the FDA for Activatm Product Group Including Bioabsorbable Devices Activapin Fusion, Activanailtm Conicaltm.
| Device ID | K080879 |
| 510k Number | K080879 |
| Device Name: | ACTIVATM PRODUCT GROUP INCLUDING BIOABSORBABLE DEVICES ACTIVAPIN FUSION, ACTIVANAILTM CONICALTM |
| Classification | Pin, Fixation, Smooth |
| Applicant | BIORETEC LTD HERMIAKATU 22 MODULIGHT BLDG Tampere, FI Fi-33720 |
| Contact | Mari Ruotsalainen |
| Correspondent | Mari Ruotsalainen BIORETEC LTD HERMIAKATU 22 MODULIGHT BLDG Tampere, FI Fi-33720 |
| Product Code | HTY |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-31 |
| Decision Date | 2008-06-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06438394000018 | K080879 | 000 |
| 06438394002333 | K080879 | 000 |
| 06438394006669 | K080879 | 000 |
| 06438394006676 | K080879 | 000 |
| 06438394006553 | K080879 | 000 |
| 06438394006645 | K080879 | 000 |
| 06438394006652 | K080879 | 000 |
| 06438394006508 | K080879 | 000 |
| 06438394006522 | K080879 | 000 |
| 06438394006539 | K080879 | 000 |
| E302BANCO15109 | K080879 | 000 |
| E302BANCO15159 | K080879 | 000 |
| E302BANCO15209 | K080879 | 000 |
| E302BANCO15259 | K080879 | 000 |
| E302BANCO15309 | K080879 | 000 |
| E302BANCO15609 | K080879 | 000 |
| 06438394006546 | K080879 | 000 |
| 06438394002326 | K080879 | 000 |
| 06438394000025 | K080879 | 000 |
| 06438394000032 | K080879 | 000 |
| 06438394000049 | K080879 | 000 |
| 06438394000056 | K080879 | 000 |
| 06438394000063 | K080879 | 000 |
| 06438394000070 | K080879 | 000 |
| 06438394000087 | K080879 | 000 |
| 06438394000094 | K080879 | 000 |
| 06438394000100 | K080879 | 000 |
| 06438394000117 | K080879 | 000 |
| 06438394000124 | K080879 | 000 |
| 06438394000155 | K080879 | 000 |
| 06438394000179 | K080879 | 000 |
| 06438394000216 | K080879 | 000 |
| 06438394002319 | K080879 | 000 |
| E302BANCO20159 | K080879 | 000 |
| E302BANCO20209 | K080879 | 000 |
| E302BANCO20259 | K080879 | 000 |
| E302BAP27609 | K080879 | 000 |
| E302BAP27709 | K080879 | 000 |
| E302BAP32409 | K080879 | 000 |
| E302BAP32509 | K080879 | 000 |
| E302BAP32609 | K080879 | 000 |
| E302BAP32709 | K080879 | 000 |
| E302BDIP15009 | K080879 | 000 |
| E302BDIP20009 | K080879 | 000 |
| E302BDIP27009 | K080879 | 000 |
| E302BDIP32009 | K080879 | 000 |
| E302RFSP0159 | K080879 | 000 |
| E302RFSP0209 | K080879 | 000 |
| E302RFSP0279 | K080879 | 000 |
| E302RFSPA159 | K080879 | 000 |
| E302RFSPA209 | K080879 | 000 |
| E302BAP27509 | K080879 | 000 |
| E302BAP27409 | K080879 | 000 |
| E302BANCO20309 | K080879 | 000 |
| E302BANCO20609 | K080879 | 000 |
| E302BAP15209 | K080879 | 000 |
| E302BAP15309 | K080879 | 000 |
| E302BAP15409 | K080879 | 000 |
| E302BAP15509 | K080879 | 000 |
| E302BAP15609 | K080879 | 000 |
| E302BAP15709 | K080879 | 000 |
| E302BAP20209 | K080879 | 000 |
| E302BAP20309 | K080879 | 000 |
| E302BAP20409 | K080879 | 000 |
| E302BAP20509 | K080879 | 000 |
| E302BAP20609 | K080879 | 000 |
| E302BAP20709 | K080879 | 000 |
| E302BAP27309 | K080879 | 000 |
| E302RFSPA279 | K080879 | 000 |