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

Clearance record K221675

United U2 femoral head, 22mm delta ceramic head · United Orthopedic Corporation · decided 2022-11-04 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
Ceramic Femoral Head1203-5022UNITED ORTHOPEDIC CORP.KWY LPH04719886890822
Ceramic Femoral Head1203-5422UNITED ORTHOPEDIC CORP.KWY LPH04719886890846
U-Motion II1203-6422-RBUNITED ORTHOPEDIC CORP.KWY LPH04719886901139
U-Motion II1203-6022-RCUNITED ORTHOPEDIC CORP.KWY LPH04719886891171
U-Motion II1203-6422-RCUNITED ORTHOPEDIC CORP.KWY LPH04719886891195
U-Motion II1203-6222-RBUNITED ORTHOPEDIC CORP.KWY LPH04719886901122
U-Motion II1203-6022-RBUNITED ORTHOPEDIC CORP.KWY LPH04719886901115
Ceramic Femoral Head1203-5222UNITED ORTHOPEDIC CORP.KWY LPH04719886890839
U-Motion II1203-6222-RCUNITED ORTHOPEDIC CORP.KWY LPH04719886891188