The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Power Tek Ii.
| Device ID | K020761 |
| 510k Number | K020761 |
| Device Name: | POWER TEK II |
| Classification | Arthroscope |
| Applicant | BIOMET, INC. 56 EAST BELL DR. Warsaw, IN 46581 -0587 |
| Contact | Patricia S Beres |
| Correspondent | Patricia S Beres BIOMET, INC. 56 EAST BELL DR. Warsaw, IN 46581 -0587 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-03-07 |
| Decision Date | 2002-04-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304460492 | K020761 | 000 |
| 00880304460478 | K020761 | 000 |
| 00880304454538 | K020761 | 000 |