The following data is part of a premarket notification filed by Intelligent Orthopaedics Ltd with the FDA for Sterile Storm (r) Operating Kit.
| Device ID | K111001 |
| 510k Number | K111001 |
| Device Name: | STERILE STORM (R) OPERATING KIT |
| Classification | Screw, Fixation, Bone |
| Applicant | INTELLIGENT ORTHOPAEDICS LTD STAFFORDSHIRE UNIVERSITY BUSINESS VILLAGE, LEEK ROAD Stoke On Trent, Staffordshire, GB St4 2ar |
| Contact | Peter J Ogrodnik |
| Correspondent | Peter J Ogrodnik INTELLIGENT ORTHOPAEDICS LTD STAFFORDSHIRE UNIVERSITY BUSINESS VILLAGE, LEEK ROAD Stoke On Trent, Staffordshire, GB St4 2ar |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-04-11 |
| Decision Date | 2011-05-17 |
| Summary: | summary |