The following data is part of a premarket notification filed by Tecnologia Y Diseno Industrial, S.a De C.v with the FDA for Newfix Screw, Wire And Pin Fixarion System.
| Device ID | K101254 |
| 510k Number | K101254 |
| Device Name: | NEWFIX SCREW, WIRE AND PIN FIXARION SYSTEM |
| Classification | Screw, Fixation, Bone |
| Applicant | TECNOLOGIA Y DISENO INDUSTRIAL, S.A DE C.V PO BOX 506 South Lyon, MI |
| Contact | Robert J Bard, Jd |
| Correspondent | Robert J Bard, Jd TECNOLOGIA Y DISENO INDUSTRIAL, S.A DE C.V PO BOX 506 South Lyon, MI |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-05-04 |
| Decision Date | 2010-07-15 |
| Summary: | summary |