The following data is part of a premarket notification filed by Linvatec Corp. with the FDA for Bioanchor With Disposable Driver, Preloaded With One #2 Herculine Suture.
Device ID | K042778 |
510k Number | K042778 |
Device Name: | BIOANCHOR WITH DISPOSABLE DRIVER, PRELOADED WITH ONE #2 HERCULINE SUTURE |
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 | 2004-10-06 |
Decision Date | 2004-11-04 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
20845854030797 | K042778 | 000 |