The following data is part of a premarket notification filed by Linvatec Corp. with the FDA for Endopearl With Threader.
| Device ID | K993339 |
| 510k Number | K993339 |
| Device Name: | ENDOPEARL WITH THREADER |
| Classification | Fastener, Fixation, Biodegradable, Soft Tissue |
| 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 | MAI |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-10-05 |
| Decision Date | 1999-12-10 |
| Summary: | summary |