The following data is part of a premarket notification filed by Linvatec Corp. with the FDA for Biorc Anchor.
| Device ID | K990770 |
| 510k Number | K990770 |
| Device Name: | BIORC ANCHOR |
| Classification | Screw, Fixation, Bone |
| Applicant | LINVATEC CORP. 11311 CONCEPT BLVD. Largo, FL 33773 -4908 |
| Contact | Laura Seneff |
| Correspondent | Laura 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 | Yes |
| Date Received | 1999-03-09 |
| Decision Date | 1999-07-30 |
| Summary: | summary |