Atlas FDA

DUPUY CEMENT RESTRICTOR TRIALS & INSTR.

FDA 510(k) clearance K800894 · decided 1980-05-02

Clearance details

K-number
K800894
Device name
DUPUY CEMENT RESTRICTOR TRIALS & INSTR.
Applicant
Depuy, Inc.
Decision
Substantially Equivalent
Date received
1980-04-18
Decision date
1980-05-02
Days to decision
14 days
Clearance type
Traditional
Product code
JDI
Device class
2
Regulation number
888.3350
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Mchenry, IL, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
DePuy, a Johnson & Johnson company, CEMENT RESTRICTOR, Size 1, Sterile, DePuy Orthopaedics recall (Z-1686-2011)Depuy Orthopaedics, Inc.2011-03-17
DePuy, a Johnson & Johnson company, CEMENT RESTRICTOR, Size 4, Sterile, DePuy Orthopaedics recall (Z-1687-2011)Depuy Orthopaedics, Inc.2011-03-17
DePuy, a Johnson & Johnson company, CEMENT RESTRICTOR, Size 5, Sterile, DePuy Orthopaedics recall (Z-1688-2011)Depuy Orthopaedics, Inc.2011-03-17
DePuy, a Johnson & Johnson company, CEMENT RESTRICTOR, Size 3, Sterile, DePuy Orthopaedics recall (Z-1689-2011)Depuy Orthopaedics, Inc.2011-03-17
DePuy, a Johnson & Johnson company, CEMENT RESTRICTOR, Size 5, Sterile, DePuy Orthopaedics recall (Z-1690-2011)Depuy Orthopaedics, Inc.2011-03-17

PMA approvals by this applicant

RecordFirmDate
ATTUNE™ Revision Rotating Platform (RP) Knee System (P830055/S346)Depuy, Inc.2025-12-18
LCS Total Knee System (P830055/S355)Depuy, Inc.2025-12-15
LCS® Total Knee System (P830055/S354)Depuy, Inc.2025-12-11
LCS® Total Knee System (P830055/S353)Depuy, Inc.2025-12-09
LCS® Total Knee System (P830055/S352)Depuy, Inc.2025-11-26
LCS® Total Knee System (P830055/S350)Depuy, Inc.2025-09-26
LCS® Total Knee System (P830055/S349)Depuy, Inc.2025-09-09
LCS Total Knee System (P830055/S348)Depuy, Inc.2025-08-29