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510(k) K041069 · HWC Screw, Fixation, Bone

SPIRALOK ANCHOR

Applicant	Depuy Mitek, A Johnson & Johnson Company, Norwood MA, US
Decision	Substantially Equivalent, Nov 9, 2004
Received	Apr 26, 2004
Type	Traditional
FDA record	Open on fda.gov

Recalls that name K041069

Date	Firm and product	Code	Linked 510(k)
Oct 25, 2012	DePuy Mitek, Inc., a Johnson & Johnson Co. SpiraLok 5.0mm with Ethibond and needles Product Number: 222960 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in Terminated	HWC	None listed
Oct 25, 2012	DePuy Mitek, Inc., a Johnson & Johnson Co. SpiraLok 5.0mm with Panacryl and needles Product Number: 222961 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in Terminated	HWC	None listed
Oct 25, 2012	DePuy Mitek, Inc., a Johnson & Johnson Co. SpiraLok 6.5mm with Ethibond and needles Product Number: 222962 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in Terminated	HWC	None listed
Oct 25, 2012	DePuy Mitek, Inc., a Johnson & Johnson Co. SpiraLok 6.5mm with Panacryl and needles Product Number: 222963 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in Terminated	HWC	None listed
Oct 25, 2012	DePuy Mitek, Inc., a Johnson & Johnson Co. SpiraLok 5.0mm with Ethibond without needles Product Number: 222964 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use Terminated	HWC	None listed
Oct 25, 2012	DePuy Mitek, Inc., a Johnson & Johnson Co. SpiraLok 5.0mm with Panacryl without needles Product Number: 222965 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use Terminated	HWC	None listed
Oct 25, 2012	DePuy Mitek, Inc., a Johnson & Johnson Co. SpiraLok 6.5mm with Ethibond without needles Product Number: 222966 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use Terminated	HWC	None listed
Oct 25, 2012	DePuy Mitek, Inc., a Johnson & Johnson Co. Screw, fixation, boneProduct Number: 222967 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 Terminated	HWC	None listed
Oct 25, 2012	DePuy Mitek, Inc., a Johnson & Johnson Co. SpiraLok 5.0 w/Needles with Orthocord Product Number: 222968 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 Terminated	HWC	None listed
Oct 25, 2012	DePuy Mitek, Inc., a Johnson & Johnson Co. SpiraLok 5.0 w/out Needles with Orthocord Product Number: 222969 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in Terminated	HWC	None listed
Oct 25, 2012	DePuy Mitek, Inc., a Johnson & Johnson Co. SpiraLok 6.5 w/Needles with Orthocord Product Number: 222970 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 Terminated	HWC	None listed
Oct 25, 2012	DePuy Mitek, Inc., a Johnson & Johnson Co. 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 Terminated	HWC	None listed
Oct 25, 2012	DePuy Mitek, Inc., a Johnson & Johnson Co. 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 indicate Terminated	HWC	None listed
Oct 25, 2012	DePuy Mitek, Inc., a Johnson & Johnson Co. 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 indi Terminated	HWC	None listed
Oct 25, 2012	DePuy Mitek, Inc., a Johnson & Johnson Co. 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 indicate Terminated	HWC	None listed
Oct 25, 2012	DePuy Mitek, Inc., a Johnson & Johnson Co. 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 indi Terminated	HWC	None listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.