The following data is part of a premarket notification filed by Linvatec Corp. with the FDA for Pre-loaded Biostinger Hornet.
| Device ID | K020377 |
| 510k Number | K020377 |
| Device Name: | PRE-LOADED BIOSTINGER HORNET |
| Classification | Screw, Fixation, Bone |
| Applicant | LINVATEC CORP. 11311 CONCEPT BLVD. Largo, FL 33773 -4908 |
| Contact | Laura D Seneff |
| Correspondent | Laura D Seneff 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 | 2002-02-05 |
| Decision Date | 2002-05-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20845854014469 | K020377 | 000 |
| 20845854014421 | K020377 | 000 |
| 20845854013486 | K020377 | 000 |