The following data is part of a premarket notification filed by Linvatec Biomaterials, Inc. with the FDA for Modification To Smartpin.
| Device ID | K041288 |
| 510k Number | K041288 |
| Device Name: | MODIFICATION TO SMARTPIN |
| Classification | Pin, Fixation, Smooth |
| Applicant | LINVATEC BIOMATERIALS, INC. P.O. BOX 3 HERMIANKATU 6-8L Tampere, FI Fin-33720 |
| Contact | Tuija Annala |
| Correspondent | Tuija Annala LINVATEC BIOMATERIALS, INC. P.O. BOX 3 HERMIANKATU 6-8L Tampere, FI Fin-33720 |
| Product Code | HTY |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-05-13 |
| Decision Date | 2004-06-10 |
| Summary: | summary |