ORTHOPEDIATRICS ACL RECONSTRUCTIVE SYSTEM
FDA 510(k) clearance K130217 · decided 2013-06-20
Clearance details
- K-number
- K130217
- Device name
- ORTHOPEDIATRICS ACL RECONSTRUCTIVE SYSTEM
- Applicant
- OrthoPediatrics Corp.
- Decision
- Substantially Equivalent
- Date received
- 2013-01-29
- Decision date
- 2013-06-20
- Days to decision
- 142 days
- Clearance type
- Traditional
- Product code
- MBI
- Device class
- 2
- Regulation number
- 888.3040
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Warsaw, IN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ACL Sleeve Installation Tool Sizes: 6mm, 6.5mm, 7.0mm, 7.5mm, 8.0mm, 8.5mm, 9.0mm, 10.0mm recall (Z-2560-2014) | OrthoPediatrics Corp | 2014-08-29 |
| OrthoPediatrics ACL Reconstruction System is a pediatric and small stature adult ACL recon recall (Z-0579-2014) | OrthoPediatrics Corp | 2013-12-26 |