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Recognized a 510(k)/PMA number — showing its clearance record and devices.

Clearance record K100370

SYMMETRIC TOTAL KNEE AGUMENTS · Signal Medical Corp. · decided 2011-03-07 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
Coated Revision Stem22x100SIGNAL MEDICAL CORPORATIONJWHB046220811221000
Coated Revision Stem26x200SIGNAL MEDICAL CORPORATIONJWHB046220811262000
Alliant Biotech26x200MEDISURGE LLCJWHG611220811262000
Alliant Biotech22x100MEDISURGE LLCJWHG611220811221000
Femoral Wedge7-8 Posterior ThickSIGNAL MEDICAL CORPORATIONJWHB046WZC26660
Femoral Wedge 5-6 Distal FullSIGNAL MEDICAL CORPORATIONJWHB046WZC26600
Alliant Biotech10x100MEDISURGE LLCJWHG611220811101000
Coated Revision Stem24x100SIGNAL MEDICAL CORPORATIONJWHB046220811241000
Coated Revision Stem10x100SIGNAL MEDICAL CORPORATIONJWHB046220811101000
Alliant BiotechDistal Full 7-8MEDISURGE LLCJWHG611WZC26640
Alliant Biotech12x150MEDISURGE LLCJWHG611220811121500
Alliant BiotechDistal Half 7-8MEDISURGE LLCJWHG611WZC26630
Coated Revision Stem12x100SIGNAL MEDICAL CORPORATIONJWHB046220811121000
Femoral Wedge7-8 Posterior ThinSIGNAL MEDICAL CORPORATIONJWHB046WZC26650
Coated Revision Stem16x200SIGNAL MEDICAL CORPORATIONJWHB046220811162000
Alliant Biotech16x100MEDISURGE LLCJWHG611220811161000
Alliant BiotechDistal Half 3-4MEDISURGE LLCJWHG611WZC26550
Coated Revision Stem26x100SIGNAL MEDICAL CORPORATIONJWHB046220811261000
Alliant Biotech26x150MEDISURGE LLCJWHG611220811261500
Coated Revision Stem26x150SIGNAL MEDICAL CORPORATIONJWHB046220811261500
Alliant BiotechOffsetMEDISURGE LLCJWHG611220910450
Alliant BiotechPosterior Thin 5-6MEDISURGE LLCJWHG611WZC26610
Alliant Biotech22x200MEDISURGE LLCJWHG611220811222000
Alliant Biotech18x150MEDISURGE LLCJWHG611220811181500
Coated Revision Stem24x200SIGNAL MEDICAL CORPORATIONJWHB046220811242000