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Found 20 results
510(k) Data Aggregation
K Number
K203855Device Name
CoNextions TR Tendon Repair System
Manufacturer
CoNextions Medical
Date Cleared
2022-04-22
(477 days)
Product Code
GAQ
Regulation Number
878.4495Why did this record match?
Product Code :
GAQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
CoNextions TR Tendon Repair System is indicated for the repair of severed Tendons in adults (22 years of age or older). The product is intended for the following indications:
- Digital Flexor Tendons
- Digital Extensor Tendons Proximal to the Metacarpophalangeal Joints (Zones 6-8)
Device Description
The CoNextions TR Tendon Repair System consists of a single-use, sterile implant consisting of two identical stainless steel anchors implanted in either end of the injured tendon and connected by two loops of UHMWPE fiber. The implant is provided pre-loaded into an Implant Mechanism and with a Deployment Mechanism to facilitate placement.
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K Number
K193209Device Name
Wego-Stainless Steel
Manufacturer
Foosin Medical Supplies Inc., Ltd.
Date Cleared
2020-02-19
(90 days)
Product Code
GAQ, GAO
Regulation Number
878.4495Why did this record match?
Product Code :
GAQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The WEGO-STAINLESS STEEL is indicated for use in abdominal wound closure, hernia repair, sternal closure and orthopaedic procedures including cerclage and tendon repair.
Device Description
The proposed device, WEGO-STAINLESS STEEL, is monofilament, non-absorbable surgical suture composed of stainless steel. WEGO-STAINLESS STEEL is undyed and uncoated. The proposed device is composed of suture and needle. The sutures are available in a range of gauge sizes and lengths attached to stainless steel needles of varying types and sizes. WEGO-STAINLESS STEEL complies with the requirements of the United States Pharmacopoeia for Non-Absorbable Surgical Sutures.
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K Number
K172146Device Name
MERISTEEL
Manufacturer
M/s. Meril Endo Surgery Private Limited
Date Cleared
2018-02-01
(199 days)
Product Code
GAQ, GAO
Regulation Number
878.4495Why did this record match?
Product Code :
GAQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
MERISTEEL™ sutures are intended for use in abdominal wounds closure, hernia repair, sterna closure and orthopaedic procedure including cerclage & tendon repair.
Device Description
MERISTEEL™ Stainless steel suture is a monofilament, non-absorbable sterile surgical suture composed of stainless steel. This suture is available undyed and uncoated. MERISTEEL™ suture is available in a range of gauge sizes and lengths, and attached to standard stainless steel needles of various types and sizes. Stainless steel suture complies with the requirements of the United States Pharmacopoeia for Non Absorbable Surgical suture and European Pharmacopoeia for Sterile Non-Absorbable surgical strands
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K Number
K170767Device Name
Surgical Stainless Steel Suture, Stainless Steel Suture
Manufacturer
Ethicon, Inc.
Date Cleared
2017-11-01
(232 days)
Product Code
GAQ
Regulation Number
878.4495Why did this record match?
Product Code :
GAQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Stainless Steel Suture is indicated for use in abdominal wound closure, hernia repair, sternal closure and orthopaedic procedures including cerclage and tendon repair.
Device Description
Stainless Steel Suture is a sterile monofilament or multifilament, non-absorbable sterile surgical suture composed of 316L stainless steel. The suture is also available coated with polyethylene. Stainless Steel Suture is available in a range of gauge sizes and lengths, non-needled or attached to needles of various types and sizes. Stainless Steel Suture complies with the requirements of the European Pharmacopoeia (Ph. Eur.) for Sterile Non-Absorbable Strands and the United States Pharmacopoeia (USP) for Non Absorbable Surgical Sutures. The European Pharmacopoeia recognizes units of measure Metric and Ph. Eur. sizes as equivalent which is reflected on the labeling.
Stainless Steel Suture elicits a minimal acute inflammatory reaction in tissue and is not absorbed. Implantation studies in animals show that no significant change in the retention of tensile strength of the suture occurs during the lifetime of the implantation.
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K Number
K141007Device Name
DEMESTEEL (STAINLESS STEEL) NON-ABSORBABLE SUTURE
Manufacturer
DEMETECH CORP.
Date Cleared
2014-09-25
(160 days)
Product Code
GAQ
Regulation Number
878.4495Why did this record match?
Product Code :
GAQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
"DemeSTEEL" is a stainless steel suture composed of 316L stainless steel with or without needles attached, and is intended for use in abdominal wound closure, intestinal anastomosis, hernia repair, sternal closure and certain orthopedic procedures, including cerclage and tendon repair.
Device Description
Demetech's DemeSTEEL is a Monofilament and/or Multifilament Non-absorbable surgical suture composed of 316L Stainless Steel and supplied with and without needles affixed to the sutures. Demetech's DemeSTEEL Surgical Suture meets the requirements established by the United States Pharmacopeia (U.S.P.) for nonabsorbable surgical sutures. DemeSTEEL Stainless Steel sutures are composed of 316L stainless steel conforming to the FDA recognized ASTM Standard F138 Grade 2 "Stainless steel bar and wire for surgical implants".
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K Number
K140127Device Name
FERROFIBRE STAINLESS STEEL SUTURE WITH CRIMP
Manufacturer
PONTIS ORTHOPAEDICS, LLC
Date Cleared
2014-05-28
(132 days)
Product Code
GAQ
Regulation Number
878.4495Why did this record match?
Product Code :
GAQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ferroFIBRE™ Stainless Steel Suture with Crimp is intended for use in soft tissue approximation and for use in abdominal wound closure. hernia repair, sternal closure and certain orthopaedic procedures including cerclage and tendon repair
Device Description
The ferroFibre™ with Crimp is a nonabsorbable sterile surgical suture with a crimp composed of stainless steel. The ferroFibre™ with Crimp is available in USP sizes 4-0 to size 3, attached to stainless steel needles of various types and sizes. The ferroFibre™ suture was previously cleared in the K081060. A stainless steel crimp is being added to provide an alternate to knot tying. The use of the crimp for size 3-0 and 4-0 was cleared under submission K101126.
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K Number
K081060Device Name
FERROFIBRE STAINLESS STEEL SUTURES, MODEL 610 SERIES SIZES (USP) 5-0 TO #5
Manufacturer
CORE ESSENCE ORTHOPAEDICS, LLC
Date Cleared
2008-12-24
(254 days)
Product Code
GAQ
Regulation Number
878.4495Why did this record match?
Product Code :
GAQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ferroFibre 14 Stainless Steel Sutures are intended for use in soft tissue approximation and for use in abdominal wound closure, hernia repair, sternal closure and certain orthopaedic procedures including cerclage and tendon repair.
Device Description
The ferroFibre™ Stainless Steel Suture is available in United States Pharmacopocia (USP) sizes 5-0 to #5 in various lengths. The ferroFibre multifilament stainless stecl sutures are supplied storile, armed with cutting needles. The sutures are fabricated from 316 stainless steel that meets ASTM F138-03.
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K Number
K082828Device Name
SUTURTEK 360 DEGREE STERNAL CLOSURE DEVICE
Manufacturer
SUTURTEK INCORPORATED
Date Cleared
2008-10-14
(19 days)
Product Code
GAQ, GAO
Regulation Number
878.4495Why did this record match?
Product Code :
GAQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Suturtek 360° Sternal Closure Device is intended for use during thoracic surgery to hold and close the sternum after a sternotomy. It is designed to aid in the prevention of suture needle stick injuries.
Device Description
The SuturTek 360° Sternal Closure Device™ is a an instrument that is used to pass stainless steel needles through sternum for fixation with stainless steel sutures. It is used to hold and close the sternum after a sternotomy.
The device is sterilized before each use. The cartridge containing the needle (with suture attached) is loaded onto the distal end of the device. The needle is engaged by the device's internal drive mechanism and driven through the sternum to be sutured. The suture is thus passed completely through the tissue. Once the suture is in place, the device is withdrawn from the incision leaving the suture strand looped through the sternum. Additional interrupted stitches are placed in the same manner and then the ends of the suture are tied together in the usual fashion.
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K Number
K063603Device Name
SUTURTEK SURGICAL STEEL SUTURE, MODELS SC-S13, SC-S14, SC-S15, SC-S16, SC-S17
Manufacturer
SUTURTEK INCORPORATED
Date Cleared
2007-02-07
(66 days)
Product Code
GAQ
Regulation Number
878.4495Why did this record match?
Product Code :
GAQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SuturTek Surgical Steel Suture is intended for use in sternal closure.
Device Description
The SuturTek Surgical Steel Suture is a sterile, single-use, non absorbable, stainless steel monofilament suture. It is designed to remain inside the patient. It may or may not be attached to a stainless steel needle. The needle and any unused portions of suture are disposables.
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K Number
K042606Device Name
MODIFICATION TO:SYNTHES (USA) TITANIUM WIRE
Manufacturer
SYNTHES (USA)
Date Cleared
2005-05-27
(245 days)
Product Code
GAQ
Regulation Number
878.4495Why did this record match?
Product Code :
GAQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Synthes (USA) Titanium Wire is indicated for use in soft tissue approximation and/or ligation, for canthoplasty, canthopexy and/or canthal tendon repair.
Device Description
The Synthes Titanium Wire with Barb is a nonabsorbable, monofilament, sterile surgical wire with an attached barb. The 28 gauge titanium wire with barb is available in a length of 538mm and has a permanently attached stainless steel needle.
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