Atlas FDA

CLOSED FUSION PLATE, MTP PLATE, TALUS PLATE, MODEL 824077021, 22; 824677021, 22, 824071001, 824071101, 824671001, 82467

FDA 510(k) clearance K101240 · decided 2010-07-23

Clearance details

K-number
K101240
Device name
CLOSED FUSION PLATE, MTP PLATE, TALUS PLATE, MODEL 824077021, 22; 824677021, 22, 824071001, 824071101, 824671001, 82467
Applicant
DePuy Orthopaedics, Inc.
Decision
Substantially Equivalent
Date received
2010-05-04
Decision date
2010-07-23
Days to decision
80 days
Clearance type
Traditional
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

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
CERAMAX® Ceramic Total Hip System (P070026/S128)DePuy Orthopaedics, Inc.2026-07-24
CERAMAX CERAMIC HIP SYSTEM (P070026/S127)DePuy Orthopaedics, Inc.2026-06-03
Ceramax® Ceramic Hip System (P070026/S125)DePuy Orthopaedics, Inc.2026-04-29
Ceramax Ceramic Hip System (P070026/S124)DePuy Orthopaedics, Inc.2026-04-10
Ceramax® Ceramic Total Hip System (P070026/S118)DePuy Orthopaedics, Inc.2026-01-08
Ceramax Ceramic Hip System (P070026/S123)DePuy Orthopaedics, Inc.2025-12-09
CERAMAX CERAMIC HIP SYSTEM (P070026/S121)DePuy Orthopaedics, Inc.2025-08-05
CERAMAX CERAMIC HIP SYSTEM (P070026/S122)DePuy Orthopaedics, Inc.2025-08-01