The following data is part of a premarket notification filed by Orthopaedic Implant Company with the FDA for Oic External Fixation System.
Device ID | K171211 |
510k Number | K171211 |
Device Name: | OIC External Fixation System |
Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
Applicant | Orthopaedic Implant Company 770 Smithridge Dr. #400 Reno, NV 89502 |
Contact | Douglas Fulton |
Correspondent | Douglas Fulton Orthopaedic Implant Company 770 Smithridge Dr. #400 Reno, NV 89502 |
Product Code | KTT |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-04-25 |
Decision Date | 2017-09-27 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10811998038268 | K171211 | 000 |
M696BTHP0545M0 | K171211 | 000 |
M696BTHP0555L0 | K171211 | 000 |
M696BTHP0565L0 | K171211 | 000 |
M696STHP04200 | K171211 | 000 |
M696STHP04300 | K171211 | 000 |
M696STHP0535M0 | K171211 | 000 |
M696STHP0545M0 | K171211 | 000 |
M696STHP0555L0 | K171211 | 000 |
M696STHP0565L0 | K171211 | 000 |
M696TFP052500 | K171211 | 000 |
10811998038350 | K171211 | 000 |
10811998038367 | K171211 | 000 |
10811998038374 | K171211 | 000 |
M696BTHP0535M0 | K171211 | 000 |
M696BTHP04300 | K171211 | 000 |
10811998038275 | K171211 | 000 |
10811998038282 | K171211 | 000 |
10811998038299 | K171211 | 000 |
10811998038305 | K171211 | 000 |
10811998038312 | K171211 | 000 |
10811998038398 | K171211 | 000 |
10811998038404 | K171211 | 000 |
10811998038411 | K171211 | 000 |
10811998038428 | K171211 | 000 |
10811998038435 | K171211 | 000 |
10811998038442 | K171211 | 000 |
10811998038459 | K171211 | 000 |
M696BTHP04200 | K171211 | 000 |
10811998038381 | K171211 | 000 |
10811998038466 | K171211 | 000 |
M696XBR111500 | K171211 | 000 |
M696XBR112000 | K171211 | 000 |
M696XBR112500 | K171211 | 000 |
M696XBR113000 | K171211 | 000 |
M696XBR113500 | K171211 | 000 |
M696XBR114000 | K171211 | 000 |
M696XBR114500 | K171211 | 000 |
M696XBR115000 | K171211 | 000 |
M696XBR115500 | K171211 | 000 |
M696XBR116000 | K171211 | 000 |
10811998038206 | K171211 | 000 |
M69601EXF000 | K171211 | 000 |
10811998038558 | K171211 | 000 |
M696XBR111000 | K171211 | 000 |
M696EXFP900 | K171211 | 000 |
10811998038473 | K171211 | 000 |
10811998038480 | K171211 | 000 |
10811998038497 | K171211 | 000 |
10811998038503 | K171211 | 000 |
10811998038510 | K171211 | 000 |
10811998038527 | K171211 | 000 |
10811998038534 | K171211 | 000 |
10811998038541 | K171211 | 000 |
M696CAP05251 | K171211 | 000 |
M696EXFC11050 | K171211 | 000 |
M696EXFMC050 | K171211 | 000 |
M696EXFP000 | K171211 | 000 |
M696EXFP300 | K171211 | 000 |
20811998038326 | K171211 | 000 |