The following data is part of a premarket notification filed by Technologia Y Diseno Industrial, S.a De C.v with the FDA for Newfix External Fixation System.
| Device ID | K101338 |
| 510k Number | K101338 |
| Device Name: | NEWFIX EXTERNAL FIXATION SYSTEM |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | TECHNOLOGIA Y DISENO INDUSTRIAL, S.A DE C.V PO BOX 506 South Lyon, MI 48178 |
| Contact | Robert Bard |
| Correspondent | Robert Bard TECHNOLOGIA Y DISENO INDUSTRIAL, S.A DE C.V PO BOX 506 South Lyon, MI 48178 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-05-12 |
| Decision Date | 2011-03-14 |
| Summary: | summary |