DePuy Mitek, Inc., a Johnson & Johnson Co.

All lot codes

Orthopedic Devices

2

Yes

Worldwide Distribution - USA (nationwide) and the countries of AE, AR, AT, AU, BE, BR, CA,, CH,CL .CN, CO, CZ,DE, DK, EC, ES, FI, FR GB, GP, GR, IE, IL, IN, IT, KR, LU, LY, MX, NC NL, NO, NZ, PE, PL PT, RE, RU, SG, SI, TH, TN, TR, UG ,UY , VE, and ZA.

SpiraLok 6.5 w/out Needles with violet and blue Orthocord || Product Number: 222988 || SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow

All lot codes

Orthopedic Devices

2

Yes

Worldwide Distribution - USA (nationwide) and the countries of AE, AR, AT, AU, BE, BR, CA,, CH,CL .CN, CO, CZ,DE, DK, EC, ES, FI, FR GB, GP, GR, IE, IL, IN, IT, KR, LU, LY, MX, NC NL, NO, NZ, PE, PL PT, RE, RU, SG, SI, TH, TN, TR, UG ,UY , VE, and ZA.

SpiraLok 6.5 w/Needles with violet and blue Orthocord || Product Number: 222987 || SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow

All lot codes

Orthopedic Devices

2

Yes

Worldwide Distribution - USA (nationwide) and the countries of AE, AR, AT, AU, BE, BR, CA,, CH,CL .CN, CO, CZ,DE, DK, EC, ES, FI, FR GB, GP, GR, IE, IL, IN, IT, KR, LU, LY, MX, NC NL, NO, NZ, PE, PL PT, RE, RU, SG, SI, TH, TN, TR, UG ,UY , VE, and ZA.

SpiraLok 5.0 w/out Needles with violet and blue Orthocord || Product Number: 222986 || SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow

All lot codes

Orthopedic Devices

2

Yes

Worldwide Distribution - USA (nationwide) and the countries of AE, AR, AT, AU, BE, BR, CA,, CH,CL .CN, CO, CZ,DE, DK, EC, ES, FI, FR GB, GP, GR, IE, IL, IN, IT, KR, LU, LY, MX, NC NL, NO, NZ, PE, PL PT, RE, RU, SG, SI, TH, TN, TR, UG ,UY , VE, and ZA.

SpiraLok 5.0 w/Needles with violet and blue Orthocord || Product Number: 222985 || SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow

All lot codes

Orthopedic Devices

2

Yes

Worldwide Distribution - USA (nationwide) and the countries of AE, AR, AT, AU, BE, BR, CA,, CH,CL .CN, CO, CZ,DE, DK, EC, ES, FI, FR GB, GP, GR, IE, IL, IN, IT, KR, LU, LY, MX, NC NL, NO, NZ, PE, PL PT, RE, RU, SG, SI, TH, TN, TR, UG ,UY , VE, and ZA.

SpiraLok 6.5 w/out Needles with Orthocord || Product Number: 222971 || SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow