Atlas FDA

JTS EXTENDEABLE IMPLANT

FDA 510(k) clearance K092138 · decided 2011-03-22

Clearance details

K-number
K092138
Device name
JTS EXTENDEABLE IMPLANT
Applicant
Stanmore Implants Worldwide , Ltd.
Decision
Substantially Equivalent
Date received
2009-07-15
Decision date
2011-03-22
Days to decision
615 days
Clearance type
Traditional
Product code
KRO
Device class
2
Regulation number
888.3510
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Washington, DC, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.