RESPONSE™ Rib and Pelvic System
FDA 510(k) clearance K233105 · decided 2024-01-20
Clearance details
- K-number
- K233105
- Device name
- RESPONSE™ Rib and Pelvic System
- Applicant
- OrthoPediatrics Corp.
- Decision
- Substantially Equivalent
- Date received
- 2023-09-27
- Decision date
- 2024-01-20
- Days to decision
- 115 days
- Clearance type
- Traditional
- Product code
- MDI
- Device class
- 2
- Regulation number
- 888.3070
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Warsaw, IN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Vertical Expandable Prosthetic Titanium Rib (K142587) | Depuy Synthes Spine, Inc. | 2014-11-18 |
Recalls involving this device
No recalls on record reference this clearance.