The following data is part of a premarket notification filed by Linvatec Corp. with the FDA for Pre-loaded Ultrafix Rc.
| Device ID | K013553 |
| 510k Number | K013553 |
| Device Name: | PRE-LOADED ULTRAFIX RC |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| 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 | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-10-25 |
| Decision Date | 2001-12-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20845854040284 | K013553 | 000 |