The following data is part of a premarket notification filed by Linvatec Corp. with the FDA for Bioscrew Xtralok.
| Device ID | K013131 |
| 510k Number | K013131 |
| Device Name: | BIOSCREW XTRALOK |
| Classification | Screw, Fixation, Bone |
| Applicant | LINVATEC CORP. 11311 CONCEPT BLVD. Largo, FL 33773 -4908 |
| Contact | Laura D Seneff |
| Correspondent | Laura D Seneff LINVATEC CORP. 11311 CONCEPT BLVD. Largo, FL 33773 -4908 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-09-19 |
| Decision Date | 2002-06-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20845854014162 | K013131 | 000 |
| 20845854013875 | K013131 | 000 |
| 20845854013868 | K013131 | 000 |
| 20845854013790 | K013131 | 000 |
| 20845854013455 | K013131 | 000 |
| 20845854013448 | K013131 | 000 |