The following data is part of a premarket notification filed by Orthopediatrics, Corp. with the FDA for Orthopediatrics Acl Reconstructive System.
| Device ID | K130217 |
| 510k Number | K130217 |
| Device Name: | ORTHOPEDIATRICS ACL RECONSTRUCTIVE SYSTEM |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | ORTHOPEDIATRICS, CORP. 2850 FRONTIER DRIVE Warsaw, IN 46582 |
| Contact | Mark Fox |
| Correspondent | Mark Fox ORTHOPEDIATRICS, CORP. 2850 FRONTIER DRIVE Warsaw, IN 46582 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-01-29 |
| Decision Date | 2013-06-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841132122242 | K130217 | 000 |
| 00841132122129 | K130217 | 000 |
| 00841132122136 | K130217 | 000 |
| 00841132122143 | K130217 | 000 |
| 00841132122150 | K130217 | 000 |
| 00841132122167 | K130217 | 000 |
| 00841132122174 | K130217 | 000 |
| 00841132122181 | K130217 | 000 |
| 00841132122198 | K130217 | 000 |
| 00841132122204 | K130217 | 000 |
| 00841132122211 | K130217 | 000 |
| 00841132122228 | K130217 | 000 |
| 00841132122235 | K130217 | 000 |
| 00841132122112 | K130217 | 000 |