Atlas FDA

UNIVERSAL LOCKING SYSTEM, 2.7MM PLATES & SCREWS

FDA 510(k) clearance K063303 · decided 2006-11-22

Clearance details

K-number
K063303
Device name
UNIVERSAL LOCKING SYSTEM, 2.7MM PLATES & SCREWS
Applicant
Zimmer, Inc.
Decision
Substantially Equivalent
Date received
2006-11-01
Decision date
2006-11-22
Days to decision
21 days
Clearance type
Special
Product code
HRS
Device class
2
Regulation number
888.3030
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Warsaw, IN, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Zimmer Plates and Screws (ZPS) 2.7 mm Cortical Screw SelfTapping, 14 mm Length 47482701401 recall (Z-1674-2016)Zimmer Manufacturing B.V.2016-05-16
Product 5 consists of all products under product code HWC, and same usage: Item no: 474827 recall (Z-1103-2016)Zimmer Manufacturing B.V.2016-03-12
1.5 X 6 CORT SCREW HEX/SE 2.0 X 6 CORT SCREW HEX/SE 2.0 X 10 CORT SCREW CRUCI 2.0 X 12 COR recall (Z-1042-2014)Zimmer, Inc.2014-02-20

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