Atlas FDA

LINK MP RECONSTRUCTION HIP

FDA 510(k) clearance K955296 · decided 1996-02-14

Clearance details

K-number
K955296
Device name
LINK MP RECONSTRUCTION HIP
Applicant
Link America, Inc.
Decision
Substantially Equivalent
Date received
1995-11-16
Decision date
1996-02-14
Days to decision
90 days
Clearance type
Traditional
Product code
JDI
Device class
2
Regulation number
888.3350
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Indianapolis, IN, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/12, Stem size 00, prox. Stem di recall (Z-2060-2013)Waldemar Link GmbH & Co. KG (Corp. Hq.)2013-08-26
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/14, Stem size 001, prox. Stem d recall (Z-2061-2013)Waldemar Link GmbH & Co. KG (Corp. Hq.)2013-08-26
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/16, Stem size 002, prox. Stem d recall (Z-2062-2013)Waldemar Link GmbH & Co. KG (Corp. Hq.)2013-08-26
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/18, Stem size 003, prox. Stem d recall (Z-2063-2013)Waldemar Link GmbH & Co. KG (Corp. Hq.)2013-08-26
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/20, Stem size 004, prox. Stem d recall (Z-2064-2013)Waldemar Link GmbH & Co. KG (Corp. Hq.)2013-08-26
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/22, Stem size 005, prox. Stem d recall (Z-2065-2013)Waldemar Link GmbH & Co. KG (Corp. Hq.)2013-08-26
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/25, Stem size 006, prox. Stem d recall (Z-2066-2013)Waldemar Link GmbH & Co. KG (Corp. Hq.)2013-08-26
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/12, Stem size 0, prox. Stem dia recall (Z-2067-2013)Waldemar Link GmbH & Co. KG (Corp. Hq.)2013-08-26
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/14, Stem size 01, prox. Stem di recall (Z-2068-2013)Waldemar Link GmbH & Co. KG (Corp. Hq.)2013-08-26
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/16, Stem size 02, prox. Stem di recall (Z-2069-2013)Waldemar Link GmbH & Co. KG (Corp. Hq.)2013-08-26
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/18, Stem size 03, prox. Stem di recall (Z-2070-2013)Waldemar Link GmbH & Co. KG (Corp. Hq.)2013-08-26
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/20, Stem size 04, prox. Stem di recall (Z-2071-2013)Waldemar Link GmbH & Co. KG (Corp. Hq.)2013-08-26
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/22, Stem size 05, prox. Stem di recall (Z-2072-2013)Waldemar Link GmbH & Co. KG (Corp. Hq.)2013-08-26
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/25, Stem size 06, prox. Stem di recall (Z-2073-2013)Waldemar Link GmbH & Co. KG (Corp. Hq.)2013-08-26
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/12, Stem size S-0, prox. Stem d recall (Z-2074-2013)Waldemar Link GmbH & Co. KG (Corp. Hq.)2013-08-26
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/14, Stem size S-1, prox. Stem d recall (Z-2075-2013)Waldemar Link GmbH & Co. KG (Corp. Hq.)2013-08-26
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/16, Stem size S-2, prox. Stem d recall (Z-2076-2013)Waldemar Link GmbH & Co. KG (Corp. Hq.)2013-08-26
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/18, Stem size S-3, prox. Stem d recall (Z-2077-2013)Waldemar Link GmbH & Co. KG (Corp. Hq.)2013-08-26
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/20, Stem size S-4, prox. Stem d recall (Z-2078-2013)Waldemar Link GmbH & Co. KG (Corp. Hq.)2013-08-26
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/22, Stem size S-5, prox. Stem d recall (Z-2079-2013)Waldemar Link GmbH & Co. KG (Corp. Hq.)2013-08-26
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/25, Stem size S-6, prox. Stem d recall (Z-2080-2013)Waldemar Link GmbH & Co. KG (Corp. Hq.)2013-08-26