The following data is part of a premarket notification filed by Linvatec Corp. with the FDA for Pinn-acl Crosspin.
| Device ID | K043106 |
| 510k Number | K043106 |
| Device Name: | PINN-ACL CROSSPIN |
| Classification | Pin, Fixation, Smooth |
| Applicant | LINVATEC CORP. 11311 CONCEPT BLVD. Largo, FL 33773 -4908 |
| Contact | Elizabeth M Paul |
| Correspondent | Elizabeth M Paul LINVATEC CORP. 11311 CONCEPT BLVD. Largo, FL 33773 -4908 |
| Product Code | HTY |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-09 |
| Decision Date | 2005-01-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20845854014179 | K043106 | 000 |
| 20845854013806 | K043106 | 000 |
| 20845854013653 | K043106 | 000 |
| 20845854013646 | K043106 | 000 |
| 20845854013639 | K043106 | 000 |