Atlas FDA

MR-III

FDA 510(k) clearance K002261 · decided 2000-10-23

Clearance details

K-number
K002261
Device name
MR-III
Applicant
Smith & Nephew, Inc.
Decision
Substantially Equivalent
Date received
2000-07-25
Decision date
2000-10-23
Days to decision
90 days
Clearance type
Traditional
Product code
GAS
Device class
2
Regulation number
878.5000
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
Andover, MA, 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
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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