FDA.reportPublic FDA data

Integrity Implant

Primary DI
00817337000258
Brand
Integrity Implant
Company
Anika Therapeutics, Inc.
Model
6000101
Device description
Integrity Implant, 25mmx30mm
Published
2023-11-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OWXMesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OWXMesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of TendonGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K223538000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223538000Integrity ImplantAnika Therapeutics, Inc.2023-08-17OWX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817337000258PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817337000258008173370002588173370002580817337000258

GMDN Terms#

Term, Definition table
TermDefinition
Extra-gynaecological surgical mesh, composite-polymerA partially-bioabsorbable, implantable material (e.g., flat sheet) made of two or more polymers that includes a bioabsorbable polymer [e.g., polyglycolic acid (PGA)] and a non-bioabsorbable polymer [e.g., polyethylene (PE)] intended for extra-gynaecological, non-dental tissue repair/reinforcement application(s) [e.g., pericardial reinforcement, plastic surgery, abdominal hernia repair]. It may also be intended as a short-term scaffold for tissue regeneration. Disposable devices associated with implantation may be supplied with the mesh.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
807613393
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
00817337000364NanoFx FURS-41012026-05-21
00817337000616Hyalomatrix60002322026-02-22
00817337000418Integrity Implant60001132026-01-05
00817337000425Integrity Implant60001142025-09-19
00866142000007Hydrelle685-0152014-09-30
08033549790738Epifilm Otologic653-20014170002018-02-19
08033549790745Epidisc 2pk Otologic 8mm653-30014171002018-02-19
08033549790752EpiDisc TM Perf Patch Kit653-16014171512018-02-19
08033549790769Merogel Injectable640-023CFN 15180002016-09-24
08033549790974Epifilm Otologic653-20014170002018-11-08
08033549790981Epidisc 2pk Otologic 8mm653-30014171002018-11-08
08033549790998EpiDisc TM Perf Patch Kit653-16014171512018-11-08
08033549791117MEROGEL 2pk 4x4cm65114115170022024-04-18
08033549791124MEROGEL 1PK 4x4cm65114015170002024-04-18
08033549791063Epifilm Otologic653-20014170002022-02-04
08033549790714Merogel Nasal Dressing/Sinus Stent &Otologic Packing 2pk 4x4cm651-14115170022018-02-19
08033549790721Merogel Nasal Dressing/Sinus Stent &Otologic Packing 4x4cm651-14015170002018-02-19
08033549790776MeroGel Otologic Packing 1x5cm651-14215171002018-02-19
08033549790950Merogel Nasal Dressing/Sinus Stent &Otologic Packing 2pk 4x4cm651-14115170022020-01-15
08033549790967Merogel Nasal Dressing/Sinus Stent &Otologic Packing 4x4cm651-14015170002020-01-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810198920130TekBrace SoloTheraMicro, LLCOWX2026-04-17
00817337000418Integrity ImplantAnika Therapeutics, Inc.OWX2026-01-05
05060267134516FORCEWEB 5 mm x 500 mmXIROS LTDOWX2025-11-19
00817337000425Integrity ImplantAnika Therapeutics, Inc.OWX2025-09-19
00810198920055TekBrace SoloTheraMicro, LLCOWX2025-08-29
00810198920062TekBrace SoloTheraMicro, LLCOWX2025-08-29
05060267134271SIC GraftXIROS LTDOWX2025-08-07
05060267134493Infinity-Lock 3XIROS LTDOWX2025-08-07
05060267134509Infinity-Lock 5XIROS LTDOWX2025-08-07
00888867301931Arthrex®ARTHREX, INC.OWX2025-06-13
00888867301962Arthrex®ARTHREX, INC.OWX2025-06-13
00888867301986Arthrex®ARTHREX, INC.OWX2025-06-13
00888867301948Arthrex®ARTHREX, INC.OWX2025-06-13
00888867301955Arthrex®ARTHREX, INC.OWX2025-06-13
10888867301969Arthrex®ARTHREX, INC.OWX2025-06-13
00888867301979Arthrex®ARTHREX, INC.OWX2025-06-13
10888867301983Arthrex®ARTHREX, INC.OWX2025-06-13
05060267134301AchilloCordPLUSXIROS LTDOWX2025-03-26
07649988202230FiberLocker ImplantZuriMED Technologies AGOWX2025-02-10
07649988202247FiberLocker InstrumentZuriMED Technologies AGOWX2025-02-10
05060267134295Poly-Tape 5 mm x 500 mmXIROS LTDOWX2024-10-10
00817337000241Integrity ImplantAnika Therapeutics, Inc.OWX2023-11-09
05060267133755Pitch-Patch 30 mm x 20 mmXIROS LTDOWX2023-10-05
05060267133762Pitch-Patch 35 mm x 25 mmXIROS LTDOWX2023-10-05
05060267131812Poly-Tape 30mm x 800mmXIROS LTDOWX2023-07-03
05060267132499Poly-Tape 5 mm x 800 mm XIROS LTDOWX2022-10-14
05060267132505Poly-Tape 7 mm x 800 mm XIROS LTDOWX2022-10-14
05060267132512Poly-Tape 10 mm x 800 mm XIROS LTDOWX2022-10-14
05060267132529Poly-Tape 15 mm x 800 mm XIROS LTDOWX2022-10-14
05060267132536Poly-Tape 20 mm x 800 mm XIROS LTDOWX2022-10-14