Atlas FDA

SMITH & NEPHEW, INC., PROMOS REVERSE SHOULDER SYSTEM

FDA 510(k) clearance K081016 · decided 2008-09-05

Clearance details

K-number
K081016
Device name
SMITH & NEPHEW, INC., PROMOS REVERSE SHOULDER SYSTEM
Applicant
Smith & Nephew, Inc.
Decision
Substantially Equivalent
Date received
2008-04-09
Decision date
2008-09-05
Days to decision
149 days
Clearance type
Traditional
Product code
PHX
Device class
2
Regulation number
888.3660
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

RecordFirmDate
PROMOS Releasing Clamp (3 parts), REF 420 189, S&N 75006600, Rx only, QTY(1), non-sterile recall (Z-0960-2009)Smith & Nephew Inc2009-02-03
PROMOS Reverse, Glenosphere Loosening Adapter, REF 24 000 047, S&N 75005271, Rx only, QTY( recall (Z-0961-2009)Smith & Nephew Inc2009-02-03

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