The following data is part of a premarket notification filed by Orthopediatrics, Corp. with the FDA for Orthopediatrics Titanium Pediplates® System.
| Device ID | K171173 |
| 510k Number | K171173 |
| Device Name: | OrthoPediatrics Titanium PediPlates® System |
| Classification | Plate, Fixation, Bone |
| Applicant | OrthoPediatrics, Corp. 2850 Frontier Drive Warsaw, IN 46580 |
| Contact | Adam Cargill |
| Correspondent | Adam Cargill OrthoPediatrics, Corp. 2850 Frontier Drive Warsaw, IN 46580 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-04-21 |
| Decision Date | 2017-08-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841132145029 | K171173 | 000 |
| 00841132144855 | K171173 | 000 |
| 00841132144848 | K171173 | 000 |
| 00841132144831 | K171173 | 000 |
| 00841132144824 | K171173 | 000 |
| 00841132144817 | K171173 | 000 |
| 00841132144800 | K171173 | 000 |
| 00841132144794 | K171173 | 000 |
| 00841132144787 | K171173 | 000 |
| 00841132144770 | K171173 | 000 |
| 00841132144763 | K171173 | 000 |
| 00841132144756 | K171173 | 000 |
| 00841132144749 | K171173 | 000 |
| 00841132144732 | K171173 | 000 |
| 00841132144862 | K171173 | 000 |
| 00841132144879 | K171173 | 000 |
| 00841132144886 | K171173 | 000 |
| 00841132145012 | K171173 | 000 |
| 00841132145005 | K171173 | 000 |
| 00841132144992 | K171173 | 000 |
| 00841132144985 | K171173 | 000 |
| 00841132144978 | K171173 | 000 |
| 00841132144961 | K171173 | 000 |
| 00841132144954 | K171173 | 000 |
| 00841132144947 | K171173 | 000 |
| 00841132144930 | K171173 | 000 |
| 00841132144923 | K171173 | 000 |
| 00841132144916 | K171173 | 000 |
| 00841132144909 | K171173 | 000 |
| 00841132144893 | K171173 | 000 |
| 00841132144725 | K171173 | 000 |