Atlas FDA

MULTIPLICITY OF PRODUCTS

FDA 510(k) clearance K782123 · decided 1979-01-10

Clearance details

K-number
K782123
Device name
MULTIPLICITY OF PRODUCTS
Applicant
Depuy, Inc.
Decision
Substantially Equivalent
Date received
1978-12-27
Decision date
1979-01-10
Days to decision
14 days
Clearance type
Traditional
Product code
HRS
Device class
2
Regulation number
888.3030
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Mchenry, IL, US
Third-party review
No
Expedited review
No

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Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Xpert Ankle (K261511)Newclip Technics2026-07-28
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Recalls involving this device

No recalls on record reference this clearance.

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