The following data is part of a premarket notification filed by Linvatec Corp. with the FDA for Bioscrew Absorbable Interference Srew.
Device ID | K973758 |
510k Number | K973758 |
Device Name: | BIOSCREW ABSORBABLE INTERFERENCE SREW |
Classification | Screw, Fixation, Bone |
Applicant | LINVATEC CORP. 11311 CONCEPT BLVD. Largo, FL 33773 -4908 |
Contact | Carol A Weideman |
Correspondent | Carol A Weideman 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 | 1997-10-02 |
Decision Date | 1998-02-27 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
20845854014346 | K973758 | 000 |
20845854013622 | K973758 | 000 |
20845854013615 | K973758 | 000 |
20845854013608 | K973758 | 000 |
30845854013605 | K973758 | 000 |