FREEDOM PCK COMPONENTS
FDA 510(k) clearance K131481 · decided 2014-02-21
Clearance details
- K-number
- K131481
- Device name
- FREEDOM PCK COMPONENTS
- Applicant
- Maxx Orthopedics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-05-22
- Decision date
- 2014-02-21
- Days to decision
- 275 days
- Clearance type
- Traditional
- Product code
- JWH
- Device class
- 2
- Regulation number
- 888.3560
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Plymouth Meeting, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.