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510(k) Data Aggregation
K Number
K030031Device Name
SOFT TISSUE ANCHORING WASHERS
Manufacturer
ACCU-SPEED, INCORPORATED
Date Cleared
2003-01-28
(25 days)
Product Code
KGS
Regulation Number
878.4930Why did this record match?
Product Code :
KGS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Soft Tissue Anchoring Washers [washers], [washer, bolt nut] Indications For Use: are to be used for anchoring soft tissue to bone.
Device Description
Soft Tissue Anchoring Washers [washers], [washer, bolt nut]
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K Number
K020480Device Name
RBM
Manufacturer
SMITH & NEPHEW, INC.
Date Cleared
2002-03-12
(27 days)
Product Code
KGS, GAT
Regulation Number
878.4930Why did this record match?
Product Code :
KGS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The RBM is intended for use as a suture retention device to facilitate percutaneous or endoscopic soft tissue repair. The indications for the RBM are for use as a suture retention device to facilitate percuraneous or endoscopic soft tissue procedures such as shoulder stabilization (Bankart Repar), rotator cuff repair, meniscal repair, and gastrostomy.
Device Description
The RBM is a suture retention device manufactured from polyester suture, poly(L-lactide) bar, stainless steel needle and a plastic handle.
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K Number
K964935Device Name
SUTURE LOCK
Manufacturer
SMITH & NEPHEW ENDOSCOPY, INC.
Date Cleared
1997-02-25
(77 days)
Product Code
KGS
Regulation Number
878.4930Why did this record match?
Product Code :
KGS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Suture Lock is intended to be use to secure soft tissue to bone, by securing the placement of sutures used in surgical procedures. The Suture Lock is indicated for use in Bankart and Rotator Cuff Repair procedures.
Device Description
The Suture Lock is a sterile, single-use device manufactured from polyacetal.
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