Atlas FDA

CPT 12/14 HIP PROSTHESES, MODEL 00-8114-040/050-00

FDA 510(k) clearance K030265 · decided 2003-03-04

Clearance details

K-number
K030265
Device name
CPT 12/14 HIP PROSTHESES, MODEL 00-8114-040/050-00
Applicant
Zimmer, Inc.
Decision
Substantially Equivalent
Date received
2003-01-27
Decision date
2003-03-04
Days to decision
36 days
Clearance type
Special
Product code
JDI
Device class
2
Regulation number
888.3350
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
Product 22 consists of all product under product code: JDI and same usage: Item no: 811400 recall (Z-1120-2016)Zimmer Manufacturing B.V.2016-03-12
CPT 12/14 COCR prosthesis, hip, semi-constrained, metal/polymer, porous uncemented various recall (Z-0843-2016)Zimmer Biomet, Inc.2016-02-22
CPT 12/14 COCR (various sizes) recall (Z-1032-2014)Zimmer, Inc.2014-02-20

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