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 |