The following data is part of a premarket notification filed by The Orthopaedic Implant Company with the FDA for Oic Cannulated Screw System, Oic Sliding Hip Screw (shs) System.
| Device ID | K113123 |
| 510k Number | K113123 |
| Device Name: | OIC CANNULATED SCREW SYSTEM, OIC SLIDING HIP SCREW (SHS) SYSTEM |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | THE ORTHOPAEDIC IMPLANT COMPANY 5401 S. COTTONWOOD CT. Greenwood Village, CO 80121 |
| Contact | Kevin Walls |
| Correspondent | Kevin Walls THE ORTHOPAEDIC IMPLANT COMPANY 5401 S. COTTONWOOD CT. Greenwood Village, CO 80121 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-10-21 |
| Decision Date | 2012-01-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10811998030224 | K113123 | 000 |
| 10811998032266 | K113123 | 000 |
| M6960173120 | K113123 | 000 |
| M6960173140 | K113123 | 000 |
| M6960173150 | K113123 | 000 |
| M6960173160 | K113123 | 000 |
| M69601SHS0200 | K113123 | 000 |
| M69601SHS0210 | K113123 | 000 |
| M69601SHS0220 | K113123 | 000 |
| M69601SHS0230 | K113123 | 000 |
| M69601SHS0240 | K113123 | 000 |
| M6960401030 | K113123 | 000 |
| M6964001000 | K113123 | 000 |
| M6964001010 | K113123 | 000 |
| 10811998031559 | K113123 | 000 |
| 10811998031566 | K113123 | 000 |
| 10811998039500 | K113123 | 000 |
| 10811998030279 | K113123 | 000 |
| 10811998030217 | K113123 | 000 |
| 10811998030200 | K113123 | 000 |
| 10811998030248 | K113123 | 000 |
| 10811998030231 | K113123 | 000 |
| 10811998030255 | K113123 | 000 |
| 10811998030262 | K113123 | 000 |
| 10811998030187 | K113123 | 000 |
| M696017310QC0 | K113123 | 000 |
| M69607036P1 | K113123 | 000 |
| M69613066P1 | K113123 | 000 |
| 10811998031573 | K113123 | 000 |
| 10811998031580 | K113123 | 000 |
| 10811998030156 | K113123 | 000 |
| 10811998032044 | K113123 | 000 |
| 10811998032174 | K113123 | 000 |
| M6960145TP0 | K113123 | 000 |
| M6960173070 | K113123 | 000 |
| M69601SHS120 | K113123 | 000 |
| 10811998030194 | K113123 | 000 |
| 10811998032136 | K113123 | 000 |
| 10811998032143 | K113123 | 000 |
| M69601SHS050 | K113123 | 000 |
| M69601SHS060 | K113123 | 000 |
| M69601SHS070 | K113123 | 000 |
| M69601SHS200 | K113123 | 000 |
| 10811998032068 | K113123 | 000 |
| 10811998032204 | K113123 | 000 |
| 10811998032211 | K113123 | 000 |
| M69601SHS010 | K113123 | 000 |
| M69601SHS150 | K113123 | 000 |
| M69601SHS160 | K113123 | 000 |
| 20811998030221 | K113123 | 000 |
| 20811998030238 | K113123 | 000 |
| 20811998030245 | K113123 | 000 |
| 20811998030252 | K113123 | 000 |
| 20811998030269 | K113123 | 000 |
| 20811998032270 | K113123 | 000 |
| M69601SHS040 | K113123 | 000 |
| M6960173040 | K113123 | 000 |
| M6960140050 | K113123 | 000 |
| 10811998032228 | K113123 | 000 |
| 10811998032235 | K113123 | 000 |
| 10811998032242 | K113123 | 000 |
| M6960173110 | K113123 | 000 |
| M69601SHS080 | K113123 | 000 |
| M69601SHS090 | K113123 | 000 |
| M69601SHS170 | K113123 | 000 |
| M69601SHS180 | K113123 | 000 |
| M69601SHS190 | K113123 | 000 |
| 10811998030064 | K113123 | 000 |
| 10811998030125 | K113123 | 000 |
| 10811998032099 | K113123 | 000 |
| 10811998032105 | K113123 | 000 |
| 10811998032112 | K113123 | 000 |
| 10811998032129 | K113123 | 000 |
| 10811998032259 | K113123 | 000 |
| 20811998035394 | K113123 | 000 |