FDA.reportPublic FDA data

BioBrace

Primary DI
10653405988953
Brand
BioBrace
Company
Conmed Corporation
Model
BB23X30
Catalog number
BB23X30
Device description
BioBrace Reinforced Implant, 23 x 30 mm
Published
2024-02-12
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
OWTMesh, surgical, absorbable, abdominal hernia
OWWMesh, surgical, absorbable, orthopaedics, reinforcement of tendon
OWYMesh, surgical, collagen, orthopaedics, reinforcement of tendon

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OWTMesh, Surgical, Absorbable, Abdominal HerniaGeneral, Plastic Surgery2
OWWMesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of TendonGeneral, Plastic Surgery2
OWYMesh, Surgical, Collagen, Orthopaedics, Reinforcement Of TendonGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K203267000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203267000The BioBrace ImplantBiorez, Inc.2021-04-30OWW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20653405988950PackageGS11In Commercial Distribution
00860006566715PreviousGS10
10653405988953PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2065340598895020653405988950
00860006566715008600065667158600065667150860006566715
1065340598895310653405988953

GMDN Terms#

Term, Definition table
TermDefinition
Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobialA bioabsorbable, implantable material (e.g., flat sheet) made from animal-derived collagen intended for extra-gynaecological, non-dental tissue repair/reinforcement application(s) [e.g., pericardial reinforcement, plastic surgery, abdominal hernia repair]; some types may also be intended for use as a short-term scaffold for tissue regeneration. It is constructed of collagen, which might be cross-linked (e.g., with glutaraldehyde); it does not include antimicrobial agents/materials. Disposable devices associated with implantation may be supplied with the mesh.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length30Millimeter
Width23Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not reuse; Do not resterilize; Do not use if package damaged
Storage Environment Temperature040 Degrees Celsius
Storage Environment Temperature0 Degrees Celsius40 Degrees Celsius
Storage Environment Temperature0104 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(866)426-6633CustomerExperience@conmed.com

Regulatory Flags#

DUNS number
071595540
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20653405546501Y-KnotlessTM FlexYKF-GYKF-G2026-02-06
20653405990724Y-KnotlessTM FlexYKF-WYKF-W2026-02-06
10845854027851GENESYS PRESSFT, HI-FINB211NB2112015-10-24
10845854027875GENESYS PRESSFT, HI-FINB212NB2122015-10-24
10845854027882GENESYS PRESSFT, HI-FINB261NB2612015-10-24
10845854027905GENESYS PRESSFT, HI-FINB262NB2622015-10-24
10845854061718LASEADAPTLA3010EY10LA3010EY102020-06-01
20653405014147CONMED7-809-47-809-42016-09-24
20653405014154CONMED7-809-57-809-52016-09-24
20653405014178CONMED7-809-77-809-72016-09-24
20845854081584VIROSAFEVSOH002VSOH0022020-06-27
30653405061582DetachaTip3-10093-10092016-09-24
30653405061766DetachaTipIII3-43183-43182016-09-24
20845854649975ParadigmPRBSPRBS2022-02-08
20845854649982ParadigmPRBHPRBH2022-02-08
20845854655501Argo KnotlessKBC475-KITKBC475-KIT2026-09-25
20845854655518Argo KnotlessK475-KITK475-KIT2026-09-25
30845854655478ConMed AirsealSHELF-ICARTSHELF-ICART2026-09-18
20845854082482ParadigmPEZS01APEZS01A2020-11-16
20845854015466SEQUENTMR007CMR007C2015-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20845854655501Argo KnotlessConmed CorporationOWY2026-09-25
20845854655501Argo KnotlessConmed CorporationOWW2026-09-25
20845854655518Argo KnotlessConmed CorporationOWY2026-09-25
20845854655518Argo KnotlessConmed CorporationOWW2026-09-25
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
B454VTP12G10VersaCoat Flowable HydrogelAlafair Biosciences, Inc.OWW2025-12-21
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
B454VTP44G20VersaCoat Flowable HydrogelAlafair Biosciences, Inc.OWW2025-11-21
20653405990700BioBraceConmed CorporationOWW2025-10-28
30653405990707BioBraceConmed CorporationOWW2025-10-28
07332999000222TIGR® Matrix Surgical MeshNovus Scientific ABOWT2025-08-29
07332999000239TIGR® Matrix Surgical MeshNovus Scientific ABOWT2025-08-29
07332999000246TIGR® Matrix Surgical MeshNovus Scientific ABOWT2025-08-29
07332999000468TIGR® Matrix Surgical MeshNovus Scientific ABOWT2025-08-29
07332999000475TIGR® Matrix Surgical MeshNovus Scientific ABOWT2025-08-29
06975222391004SpinMedix® Absorbable Fibrous MembraneNingbo Guangyuan Zhixin Biological Technology Co., Ltd.OWW2025-05-20
06975222391011SpinMedix® Absorbable Fibrous MembraneNingbo Guangyuan Zhixin Biological Technology Co., Ltd.OWW2025-05-20