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510(k) Data Aggregation
K Number
K223822Device Name
ACTIVBRAID
Manufacturer
Embody, Inc.
Date Cleared
2023-06-02
(163 days)
Product Code
GAT
Regulation Number
878.5000Why did this record match?
Applicant Name (Manufacturer) :
Embody, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ACTIVBRAID™ is indicated for use in soft tissue approximation and/or ligation. These sutures may be incorporated, as components, into surgeries where constructs including those with allograft tissues are used for repair.
Device Description
ACTIVBRAID is a partially absorbable surgical co-braid suture constructed of nonabsorbable Ultra High Molecular Weight Polyethylene (UHMWPE) and absorbable bovine-derived type I collagen. ACTIVBRAID suture ends are stiffened with cyanoacrylate.
ACTIVBRAID is available in several sizes (sutures meet U.S. Pharmacopeia standards for nonabsorbable sutures, except diameter). Sutures are oversized in diameter. ACTIVBRAID is provided in pre-cut lengths with and without needles. Suture strands that are dyed (Chromium Cobalt-Aluminum Oxide or D&C Black No. 4) are made of UHMWPE.
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K Number
K220867Device Name
Tapestry Biointegrative Implant
Manufacturer
Embody, Inc.
Date Cleared
2022-05-23
(59 days)
Product Code
OWY
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
Embody, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
TAPESTRY® Biointegrative Implant is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue.
Device Description
The TAPESTRY® Biointegrative Implant is composed of collagen and poly(D,L-lactide). It is designed to function as a non-constricting, protective layer between the tendon and surrounding tissues. The implant is provided sterile for single use only. It is supplied as a standalone implant, in an insertion sleeve, or on an introducer assists in delivering the implant to the surgical site during arthroscopic procedures. The device is provided in a dual pouch configuration.
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K Number
K213958Device Name
Bioabsorbable Anchor
Manufacturer
Embody, Inc.
Date Cleared
2022-04-08
(112 days)
Product Code
MAI
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
Embody, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Bioabsorbable Anchor is indicated for the fixation of soft tissue grafts in various minimally invasive and open orthopedic surgical procedures in shoulder.
Device Description
The Bioabsorbable Anchor is an absorbable implant device that is intended to provide fixation of a prosthetic material to soft tissue and/or bone. The Bioabsorbable Anchor is composed of polydioxanone (PDO) dyed with D&C Violet No. 2. Two Bioabsorbable Anchors are provided sterile for single use only, packaged preloaded in a disposable anchor inserter instrument, the Dual Anchor Inserter. The preloaded Dual Anchor Inserter is provided in a dual sterile pouch confiquration.
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K Number
K212306Device Name
Tapestry Biointegrative Implant
Manufacturer
Embody, Inc.
Date Cleared
2021-11-02
(102 days)
Product Code
OWY
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
Embody, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
TAPESTRY® Biointegrative Implant is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue.
Device Description
The TAPESTRY® Biointegrative Implant (TAPESTRY) is composed of collagen and poly(D,Llactide). It is designed to function as a non-constricting, protective layer between the tendon and surrounding tissues. TAPESTRY is conformable and designed for easy placement between the tendon and surrounding tissue and may be secured in place using standard fixation techniques. TAPESTRY is provided sterile, non-pyrogenic, for single-use only, in a variety of sizes, ranging from 20mm x 25mm to 70mm x 50mm. TAPESTRY is available with or without a co-packaged polyethylene Insertion Sleeve, which is used to maintain the implant's orientation and to facilitate easy application onto the tendon. The Insertion Sleeve is discarded after use and not implanted. TAPESTRY is designed for stand-alone use. At the discretion of the surgeon. TAPESTRY may be hydrated with sterile isotonic solution.
Preclinical studies of TAPESTRY showed dense collagenous fibrous connective tissue ingrowth into and around the scaffolding.
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K Number
K201572Device Name
TAPESTRY Biointegrative Implant
Manufacturer
Embody, Inc.
Date Cleared
2020-10-19
(130 days)
Product Code
OWY, FTM
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
Embody, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
TAPESTRY® Biointegrative Implant is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue .
Device Description
The TAPESTRY® Biointegrative Implant device is composed of collagen and poly(D,L-lactide). It is designed to function as a non-constricting, protective layer between the tendon and surrounding tissues. TAPESTRY® is conformable and designed for easy placement between the tendon and surrounding tissue and may be secured in place using standard fixation techniques. TAPESTRY® is provided sterile, non-pyrogenic, for single-use only, in a variety of sizes, ranging from 20mm x 25mm to 70mm x 50mm. TAPESTRY® is available with or without a co-packaged polyethylene Insertion Sleeve, which is used to maintain the implant's orientation and to facilitate easy application onto the tendon. The Insertion Sleeve is discarded after use and not implanted. TAPESTRY® is designed for stand-alone use. At the discretion of the surgeon, TAPESTRY® may be hydrated with sterile isotonic solution.
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