The following data is part of a premarket notification filed by Linvatec Corp. with the FDA for Interference Screw.
Device ID | K960962 |
510k Number | K960962 |
Device Name: | INTERFERENCE SCREW |
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 | 1996-03-11 |
Decision Date | 1996-08-19 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
20845854015190 | K960962 | 000 |
20845854014919 | K960962 | 000 |
20845854014308 | K960962 | 000 |
20845854013837 | K960962 | 000 |
20845854013509 | K960962 | 000 |
20845854015220 | K960962 | 000 |