Atlas FDA

JAX

FDA 510(k) clearance K010555 · decided 2003-02-25

Clearance details

K-number
K010555
Device name
JAX
Applicant
Smith & Nephew, Inc.
Decision
Substantially Equivalent
Date received
2001-02-26
Decision date
2003-02-25
Days to decision
729 days
Clearance type
Traditional
Product code
MQV
Device class
2
Regulation number
888.3045
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Memphis, TN, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

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ASCENSION MCP (P000057/S014)Smith & Nephew, Inc.2025-08-05
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R3 DELTA CERAMIC HIP SYSTEM (P150030/S048)Smith & Nephew, Inc.2025-03-03
R3 Delta Ceramic Hip System (P150030/S045)Smith & Nephew, Inc.2025-02-28
R3™ Delta Ceramic Acetabular System (P150030/S047)Smith & Nephew, Inc.2025-02-21
R3™ Delta Ceramic Acetabular System (P150030/S046)Smith & Nephew, Inc.2025-01-16
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