The following data is part of a premarket notification filed by Biomet Manufacturing, Inc. with the FDA for Biomet Sports Medicine Anchor Devices And Ziploop Constructs.
| Device ID | K080088 |
| 510k Number | K080088 |
| Device Name: | BIOMET SPORTS MEDICINE ANCHOR DEVICES AND ZIPLOOP CONSTRUCTS |
| Classification | Screw, Fixation, Bone |
| Applicant | BIOMET MANUFACTURING, INC. 56 EAST BELL DR. Warsaw, IN 46581 -0587 |
| Contact | Robert R Friddle |
| Correspondent | Robert R Friddle BIOMET MANUFACTURING, INC. 56 EAST BELL DR. Warsaw, IN 46581 -0587 |
| Product Code | HWC |
| Subsequent Product Code | JDR |
| Subsequent Product Code | MAI |
| Subsequent Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-01-14 |
| Decision Date | 2008-06-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304644588 | K080088 | 000 |
| 00880304510074 | K080088 | 000 |
| 00880304507098 | K080088 | 000 |
| 00880304507081 | K080088 | 000 |
| 00880304507074 | K080088 | 000 |