The following data is part of a premarket notification filed by Linvatec Corp. with the FDA for Bioscrew Xtralok, 8x35mm & 8x40mm Violet.
| Device ID | K050497 |
| 510k Number | K050497 |
| Device Name: | BIOSCREW XTRALOK, 8X35MM & 8X40MM VIOLET |
| Classification | Screw, Fixation, Bone |
| Applicant | LINVATEC CORP. 11311 CONCEPT BLVD. Largo, FL 33773 -4908 |
| Contact | Elizabeth Paul |
| Correspondent | Elizabeth Paul LINVATEC CORP. 11311 CONCEPT BLVD. Largo, FL 33773 -4908 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-02-28 |
| Decision Date | 2005-03-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20845854014377 | K050497 | 000 |
| 20845854013493 | K050497 | 000 |