The following data is part of a premarket notification filed by Intelligent Orthopaedics Ltd with the FDA for Storm Operating Kit, Model 1-10-0.
| Device ID | K061607 |
| 510k Number | K061607 |
| Device Name: | STORM OPERATING KIT, MODEL 1-10-0 |
| Classification | Pin, Fixation, Smooth |
| Applicant | INTELLIGENT ORTHOPAEDICS LTD BRIERFIELD MILL Brierfield, Nelson, GB Bb9 5nj |
| Contact | Neil Mc Lachlan |
| Correspondent | Neil Mc Lachlan INTELLIGENT ORTHOPAEDICS LTD BRIERFIELD MILL Brierfield, Nelson, GB Bb9 5nj |
| Product Code | HTY |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-09 |
| Decision Date | 2006-07-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060309870297 | K061607 | 000 |