The following data is part of a premarket notification filed by Howmedica Osteonics Corp Dba Stryker Orthopaedics with the FDA for The Varia Fibula Locked Plating System Line Extension Addition Of Straight Plates.
| Device ID | K102282 |
| 510k Number | K102282 |
| Device Name: | THE VARIA FIBULA LOCKED PLATING SYSTEM LINE EXTENSION ADDITION OF STRAIGHT PLATES |
| Classification | Plate, Fixation, Bone |
| Applicant | HOWMEDICA OSTEONICS CORP DBA STRYKER ORTHOPAEDICS 325 Corporate Drive Mahwah, NJ 07430 |
| Contact | Stephanie Fitts |
| Correspondent | Stephanie Fitts HOWMEDICA OSTEONICS CORP DBA STRYKER ORTHOPAEDICS 325 Corporate Drive Mahwah, NJ 07430 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-08-12 |
| Decision Date | 2010-12-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613252256168 | K102282 | 000 |
| 04546540667847 | K102282 | 000 |
| 04546540667830 | K102282 | 000 |
| 04546540667823 | K102282 | 000 |
| 04546540667816 | K102282 | 000 |
| 04546540667809 | K102282 | 000 |
| 04546540667793 | K102282 | 000 |
| 04546540667786 | K102282 | 000 |
| 04546540667779 | K102282 | 000 |
| 04546540667762 | K102282 | 000 |
| 04546540667854 | K102282 | 000 |
| 07613252221944 | K102282 | 000 |
| 07613252256151 | K102282 | 000 |
| 07613252256144 | K102282 | 000 |
| 07613252256137 | K102282 | 000 |
| 07613252256120 | K102282 | 000 |
| 07613252222040 | K102282 | 000 |
| 07613252222026 | K102282 | 000 |
| 07613252222002 | K102282 | 000 |
| 07613252221975 | K102282 | 000 |
| 07613252221968 | K102282 | 000 |
| 04546540667755 | K102282 | 000 |