FDA.reportPublic FDA data

BioBrace

Primary DI
20653405990151
Brand
BioBrace
Company
Conmed Corporation
Model
BB40X60-FA
Catalog number
BB40X60-FA
Device description
BioBrace® Reinforced Implant, Foot & Ankle, 40 x 60 mm
Published
2024-09-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
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
K241906000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241906000BioBrace® Reinforced ImplantConmed Corporation2024-07-29OWW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20653405990151PackageGS11In Commercial Distribution
10653405990154PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2065340599015120653405990151
1065340599015410653405990154

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length60Millimeter
Width40Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

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

Regulatory Flags#

DUNS number
071595540
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
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
20845854655518Argo KnotlessConmed CorporationOWY2026-09-25
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
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
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