Atlas FDA

STRYKER PATIENT SPECIFIC POLYMER IMPLANT

FDA 510(k) clearance K043250 · decided 2005-04-15

Clearance details

K-number
K043250
Device name
STRYKER PATIENT SPECIFIC POLYMER IMPLANT
Applicant
Stryker Leibinger
Decision
Substantially Equivalent
Date received
2004-11-23
Decision date
2005-04-15
Days to decision
143 days
Clearance type
Traditional
Product code
KKY
Device class
2
Regulation number
878.3500
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
Kalamazoo, MI, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Stryker Custom Cranial Implant Kit, small. Distributed by Stryker Craniomaxillofacial, Kal recall (Z-0509-2009)Stryker Craniomaxillofacial Division2008-12-18
Stryker Custom Cranial Implant Kit, medium. Distributed by Stryker Craniomaxillofacial, Ka recall (Z-0510-2009)Stryker Craniomaxillofacial Division2008-12-18
Stryker Custom Cranial Implant Kit, large. Distributed by Stryker Craniomaxillofacial, Kal recall (Z-0511-2009)Stryker Craniomaxillofacial Division2008-12-18
Stryker Custom Cranial Implant Kit, extra large. Distributed by Stryker Craniomaxillofacia recall (Z-0512-2009)Stryker Craniomaxillofacial Division2008-12-18