ENDOPEARL
Fastener, Fixation, Biodegradable, Soft Tissue
LINVATEC CORP.
The following data is part of a premarket notification filed by Linvatec Corp. with the FDA for Endopearl.
Pre-market Notification Details
| Device ID | K984171 |
| 510k Number | K984171 |
| Device Name: | ENDOPEARL |
| Classification | Fastener, Fixation, Biodegradable, Soft Tissue |
| 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 | MAI |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-20 |
| Decision Date | 1999-04-29 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20845854014292 | K984171 | 000 |
| 20845854013776 | K984171 | 000 |
| 20845854013578 | K984171 | 000 |
Trademark Results [ENDOPEARL]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ENDOPEARL 75585247 2400782 Live/Registered |
CONMED CORPORATION 1998-11-09 |
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