Daytona® Small Stature Growth Rod Conversion Set
FDA 510(k) clearance K193224 · decided 2020-02-13
Clearance details
- K-number
- K193224
- Device name
- Daytona® Small Stature Growth Rod Conversion Set
- Applicant
- SeaSpine Orthopedics Corporation
- Decision
- Substantially Equivalent
- Date received
- 2019-11-22
- Decision date
- 2020-02-13
- Days to decision
- 83 days
- Clearance type
- Traditional
- Product code
- PGM
- Device class
- 2
- Regulation number
- 888.3070
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Carlsbad, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.