Atlas FDA

SYNTHES (USA) 2.4MM VA-LCP TWO-COLUMN NARROW VOLAR DISTAL RADIUS

FDA 510(k) clearance K092556 · decided 2009-11-17

Clearance details

K-number
K092556
Device name
SYNTHES (USA) 2.4MM VA-LCP TWO-COLUMN NARROW VOLAR DISTAL RADIUS
Applicant
Synthes (Usa)
Decision
Substantially Equivalent
Date received
2009-08-20
Decision date
2009-11-17
Days to decision
89 days
Clearance type
Traditional
Product code
HRS
Device class
2
Regulation number
888.3030
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
West Chester, PA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Synthes 2.4mm VA-LCP Two Column Volar Distal Radius Plate and Torque limiting attachment, recall (Z-2057-2013)Synthes (USA) Products LLC2013-08-26

PMA approvals by this applicant

RecordFirmDate
NORIAN SRS BONE CEMENT (P970010/S004)Synthes (Usa)2000-08-31
NORIAN SRS CEMENT (P970010/S002)Synthes (Usa)2000-04-28
NORIAN SRS CEMENT (P970010/S001)Synthes (Usa)1999-07-16
NORIAN SKELETAL REPAIR SYSTEM (SRS) CANCELLOUS BONE CEMENT (P970010)Synthes (Usa)1998-12-23