Atlas FDA

COFIELD TOTAL SHOULDER SYSTEM

FDA 510(k) clearance K070565 · decided 2007-05-18

Clearance details

K-number
K070565
Device name
COFIELD TOTAL SHOULDER SYSTEM
Applicant
Smith & Nephew, Inc.
Decision
Substantially Equivalent
Date received
2007-02-28
Decision date
2007-05-18
Days to decision
79 days
Clearance type
Abbreviated
Product code
MBF
Device class
2
Regulation number
888.3670
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

RecordFirmDate
Ascension MCP (P000057/S013)Smith & Nephew, Inc.2025-12-31
ASCENSION MCP (P000057/S014)Smith & Nephew, Inc.2025-08-05
R3™ Delta Ceramic Acetabular System (P150030/S049)Smith & Nephew, Inc.2025-04-17
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
BIRMINGHAM HIP™ RESURFACING (BHR) SYSTEM (P040033/S039)Smith & Nephew, Inc.2025-01-10