FDA.reportPublic FDA data

TAPESTRY BIointegrative Implant with Insertion Sleeve

Primary DI
00810063820008
Brand
TAPESTRY BIointegrative Implant with Insertion Sleeve
Company
Embody, Inc.
Model
TP-7050-02
Published
2020-11-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OWYMesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OWYMesh, Surgical, Collagen, Orthopaedics, Reinforcement Of TendonGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K201572000
K212306000
K252647000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201572000TAPESTRY Biointegrative ImplantEmbody, Inc.2020-10-19OWY
K212306000Tapestry Biointegrative ImplantEmbody, Inc.2021-11-02OWY
K252647000Tapestry Biointegrative ImplantEmbody, Inc.2025-09-19OWY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810063820008PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810063820008008100638200088100638200080810063820008

GMDN Terms#

Term, Definition table
TermDefinition
Multi-purpose surgical mesh, biologic-polymer compositeA flat or three-dimensional (3-D) implantable material comprised of both a bioabsorbable animal-derived biologic (e.g., porcine collagen) and a non-bioabsorbable synthetic polymer (e.g., polypropylene) intended for multiple defective tissue repair applications at different anatomical zones (e.g., breast, cardiac, abdominal) that includes an extra-abdominal application(s) [e.g., cardiac, plastic surgery, breast reconstruction]. It may also be used as a short-term scaffold for tissue regeneration. Disposable devices associated with implantation (e.g., introducer needles, trocars) may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height50Millimeter
Width70Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature59 Degrees Fahrenheit86 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18337490981customercare@embody-inc.com

Regulatory Flags#

DUNS number
079544913
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810063820459TAPESTRY Biointegrative Implant with IntroducerTR-2626-21TR-2626-212023-09-21
00810063820466TAPESTRY Biointegrative Implant with IntroducerTR-2626-31TR-2626-312023-09-21
00810063820039Tapestry Biointegrative ImplantTP-2030-012023-05-11
00810063820077Tapestry Biointegrative ImplantTS-4030-022023-05-11
00810063820169Embody CannulaEM-A001-01EM-A001-012022-06-02
00810063820176Embody CannulaEM-A002-01EM-A002-012022-06-02
00810063820183Embody CannulaEM-A003-01EM-A003-012022-06-02
00810063820107TAPESTRY Biointegrative Implant with IntroducerTR-3030-21TR-3030-212022-06-01
00810063820138TAPESTRY Biointegrative Implant with IntroducerTR-3030-31TR-3030-312022-06-01
00810063820060TAPESTRY Biointegrative ImplantTS-5040-022021-04-01
00810063820015TAPESTRY Biointegrative ImplantTP-7025-022020-11-20
00810063820022TAPESTRY Biointegrative ImplantTP-2550-01TP-2550-012020-11-20
00810063820046TAPESTRY Biointegrative ImplantTP-3030-012020-11-20
00810063820053TAPESTRY Biointegrative ImplantTP-4030-012020-11-20
00810063820381ACTIVBRAIDAB-021R-1BAB-021R-1B2023-08-31
00810063820398ACTIVBRAIDAB-250T-0WAB-250T-0W2023-08-31
00810063820404ACTIVBRAIDAB-200R-1WAB-200R-1W2023-08-31
00810063820411ACTIVBRAIDAB-200R-1BAB-200R-1B2023-08-31
00810063820428ACTIVBRAIDAB-150T-1WAB-150T-1W2023-08-31
00810063820435ACTIVBRAIDAB-150T-1BAB-150T-1B2023-08-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00812337020695Medeor Tendon MatrixDSM BIOMEDICAL, INC.OWY2026-03-24
00812337020701Medeor Tendon MatrixDSM BIOMEDICAL, INC.OWY2026-03-24
00812337020794Meso Tendon MatrixDSM BIOMEDICAL, INC.OWY2026-03-24
00812337020800Meso Tendon MatrixDSM BIOMEDICAL, INC.OWY2026-03-24
00812337020817Meso Tendon MatrixDSM BIOMEDICAL, INC.OWY2026-03-24
00812337020824Meso Tendon MatrixDSM BIOMEDICAL, INC.OWY2026-03-24
05694310966443Kerecis SurgiBind® Tendon ProtectKERECIS hf.OWY2026-02-03
05694310966474Kerecis SurgiBind® Tendon ProtectKERECIS hf.OWY2026-02-03
05694310966467Kerecis SurgiBind® Tendon ProtectKERECIS hf.OWY2026-02-03
05694310966450Kerecis SurgiBind® Tendon ProtectKERECIS hf.OWY2026-02-03
00860011716730B3 GEL SystemTybr Health, Inc.OWY2025-12-17
00888867395084Arthrex®ARTHREX, INC.OWY2025-12-01
00888867395091Arthrex®ARTHREX, INC.OWY2025-12-01
00888867543133Arthrex®ARTHREX, INC.OWY2025-12-01
00888867543140Arthrex®ARTHREX, INC.OWY2025-12-01
00810063820534Tapestry Biointegrative ImplantEmbody, Inc.OWY2025-04-21
00810063820541Tapestry Biointegrative ImplantEmbody, Inc.OWY2025-04-21
10653405990123BioBraceConmed CorporationOWY2024-09-20
10653405990130BioBraceConmed CorporationOWY2024-09-20
10653405990147BioBraceConmed CorporationOWY2024-09-20
10653405990154BioBraceConmed CorporationOWY2024-09-20
20653405990120BioBraceConmed CorporationOWY2024-09-20
20653405990137BioBraceConmed CorporationOWY2024-09-20
20653405990151BioBraceConmed CorporationOWY2024-09-20
10653405988946BioBraceConmed CorporationOWY2024-02-12
10653405988939BioBraceConmed CorporationOWY2024-02-12
10653405988953BioBraceConmed CorporationOWY2024-02-12
10653405988960BioBraceConmed CorporationOWY2024-02-12
00810063820473TAPESTRY Biointegrative Implant with Introducer, w/ CannulaEmbody, Inc.OWY2024-02-09
00810063820480TAPESTRY Biointegrative Implant with Introducer, w/ CannulaEmbody, Inc.OWY2024-02-09