Atlas FDA

ZIMMER PLATES AND SCREWS SYSTEM SCREWS ONLY

FDA 510(k) clearance K112885 · decided 2011-12-19

Clearance details

K-number
K112885
Device name
ZIMMER PLATES AND SCREWS SYSTEM SCREWS ONLY
Applicant
Zimmer, Inc.
Decision
Substantially Equivalent
Date received
2011-09-30
Decision date
2011-12-19
Days to decision
80 days
Clearance type
Traditional
Product code
HWC
Device class
2
Regulation number
888.3040
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) 4.0 mm Cancellous Screw Fully Threaded, 12 mm Length 474840 recall (Z-1677-2016)Zimmer Manufacturing B.V.2016-05-16
Product 4 consists of all products under product code HWC, and same usage: Item no: 474820 recall (Z-1102-2016)Zimmer Manufacturing B.V.2016-03-12
Product 10consists of all product under product code HWC, and same usage: Item no: 4748450 recall (Z-1108-2016)Zimmer Manufacturing B.V.2016-03-12
Product 13 consists of all product under product code HWC , and same usage: Item no: 47486 recall (Z-1111-2016)Zimmer Manufacturing B.V.2016-03-12
Product 18 consists of all product under product code: HWC and same usage: Item no: 472480 recall (Z-1116-2016)Zimmer Manufacturing B.V.2016-03-12
Magna-Fx Cannulated Screw Fixation System Bone Screw Fully Threaded Sterile zimmer recall (Z-2244-2014)Zimmer, Inc.2014-08-16
Magna-Fx Cannulated Screw Fixation System Cannulated Bone Screw Sterile zimmer recall (Z-2245-2014)Zimmer, Inc.2014-08-16
6.5 mm Cancellous Screw Fully Threaded Sterile zimmer recall (Z-2246-2014)Zimmer, Inc.2014-08-16
6.5 mm Cancellous Screw 16 mm Thread Length Sterile zimmer recall (Z-2247-2014)Zimmer, Inc.2014-08-16
6.5 mm Cancellous Screw 32 mm Thread Length Sterile zimmer recall (Z-2248-2014)Zimmer, Inc.2014-08-16
6.5 mm Cancellous Screw Fully Threaded Sterile zimmer recall (Z-2249-2014)Zimmer, Inc.2014-08-16
4.5 mm Malleolar Screw Sterile zimmer recall (Z-2250-2014)Zimmer, Inc.2014-08-16
4.0 mm Cancellous Screw, Partially Threaded Sterile Zimmer recall (Z-2251-2014)Zimmer, Inc.2014-08-16
PERI SCR. 3.5MM X 10MM PERI SCR. 3.5MM X 12MM PERI SCR. 3.5MM X 14MM PERI SCR 3.5MM X 44MM recall (Z-1040-2014)Zimmer, Inc.2014-02-20
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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NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM (P060037/S094)Zimmer, Inc.2025-04-01
NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM (P060037/S092)Zimmer, Inc.2024-12-12
NexGen® LPS-Flex LPS-Mobile Bearing Knee (P060037/S091)Zimmer, Inc.2024-07-05
NexGen® LPS-Flex / LPS Mobile Bearing Knee System (P060037/S090)Zimmer, Inc.2024-05-17
NexGen LPS-Flex/LPS Mobile Bearing Knee System (P060037/S089)Zimmer, Inc.2024-04-04
NexGen® LPS-Flex/LPS Mobile Bearing Knee System (P060037/S088)Zimmer, Inc.2024-02-13