The following data is part of a premarket notification filed by Linvatec Corp. with the FDA for Bioanchor With Disposable Driver.
| Device ID | K033804 |
| 510k Number | K033804 |
| Device Name: | BIOANCHOR WITH DISPOSABLE DRIVER |
| Classification | Screw, Fixation, Bone |
| Applicant | LINVATEC CORP. 11311 CONCEPT BLVD. Largo, FL 33773 -4908 |
| Contact | Laura D Krejci |
| Correspondent | Laura D Krejci 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 | 2003-12-08 |
| Decision Date | 2003-12-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20845854030780 | K033804 | 000 |