REL-K ARTIFICAL LIMB PROSTHESIS
FDA 510(k) clearance K101859 · decided 2010-10-13
Clearance details
- K-number
- K101859
- Device name
- REL-K ARTIFICAL LIMB PROSTHESIS
- Applicant
- Rizzoli Ortopedica S.P.A.
- Decision
- Substantially Equivalent
- Date received
- 2010-07-02
- Decision date
- 2010-10-13
- Days to decision
- 103 days
- Clearance type
- Traditional
- Product code
- ISY
- Device class
- 1
- Regulation number
- 890.3420
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Watertown, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.