FDA.reportPublic FDA data

Dual Anchor Inserter Multi-Pack

Primary DI
10810063820159
Brand
Dual Anchor Inserter Multi-Pack
Company
Embody, Inc.
Model
TR-0001-D3
Catalog number
TR-0001-D3
Device description
Multi-Pack
Published
2022-11-08
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MAIFastener, Fixation, Biodegradable, Soft Tissue

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAIFastener, Fixation, Biodegradable, Soft TissueOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K213958000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213958000Bioabsorbable AnchorEmbody, Inc.2022-04-08MAI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810063820159PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081006382015910810063820159

GMDN Terms#

Term, Definition table
TermDefinition
Tendon/ligament bone anchor, bioabsorbableA bioabsorbable device designed to be implanted into bone for the attachment of tendons/ligaments/soft tissues either directly or via a suture attached to the device; typically used in arthroscopic or open surgical procedures. This device is available in various designs and sizes and is made of a material that can be chemically degraded and typically absorbed via natural body processes (e.g., a copolymer, metal alloy).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079544913
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
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
00810063820008TAPESTRY BIointegrative Implant with Insertion SleeveTP-7050-022020-11-20
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

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