Atlas FDA

2.4MM VA-LCP INTERCARPAL FUSION SYSTEM

FDA 510(k) clearance K103243 · decided 2011-01-21

Clearance details

K-number
K103243
Device name
2.4MM VA-LCP INTERCARPAL FUSION SYSTEM
Applicant
Synthes (Usa)
Decision
Substantially Equivalent
Date received
2010-11-01
Decision date
2011-01-21
Days to decision
81 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
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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