The following data is part of a premarket notification filed by Intelligent Orthopaedics Ltd with the FDA for Ios External Fixator, Model 2-0-0.
| Device ID | K070724 |
| 510k Number | K070724 |
| Device Name: | IOS EXTERNAL FIXATOR, MODEL 2-0-0 |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | INTELLIGENT ORTHOPAEDICS LTD BRIERFIELD MILL Brierfield, Nelson, GB Bb9 5nj |
| Contact | Neil Mclachlan |
| Correspondent | Neil Mclachlan INTELLIGENT ORTHOPAEDICS LTD BRIERFIELD MILL Brierfield, Nelson, GB Bb9 5nj |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-03-15 |
| Decision Date | 2007-05-16 |
| Summary: | summary |