FDA.reportPublic FDA data

SCREW D.C. 1.8 x 45mm

Primary DI
M209171190
Brand
SCREW D.C. 1.8 x 45mm
Company
BIOPRO, INC.
Model
17119
Published
2015-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
JDWPin, Fixation, Threaded

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDWPin, Fixation, ThreadedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K963433000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K963433000THREADED FIXATION PINOrthopaedic Biosystems, Ltd.1996-11-06JDW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M209171190PrimaryHIBCC0

Regulatory Flags#

DUNS number
618749857
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M209101790ENDO MD 38101792015-09-16
M209101800ENDO MD 41101802015-09-16
M209101820ENDO MD 45101822015-09-16
M209101830ENDO MD 47101832015-09-16
M209101840ENDO MD 49101842015-09-16
M209101850ENDO MD 51101852015-09-16
M209101860ENDO MD 53101862015-09-16
M209101870ENDO MD 55101872015-09-16
M209101880ENDO SH 38101882015-09-16
M209101890ENDO SH 41101892015-09-16
M209101900ENDO SH 43101902015-09-16
M209101910ENDO SH 45101912015-09-16
M209101920ENDO SH 47101922015-09-16
M209101930ENDO SH 49101932015-09-16
M209101940ENDO SH 51101942015-09-16
M209101950ENDO SH 53101952015-09-16
M209101960ENDO SH 55101962015-09-16
M209130070ENDO MODULAR CERAMIC SH 41130072015-09-16
M209130080ENDO MODULAR CERAMIC SH 43130082015-09-16
M209130090ENDO MODULAR CERAMIC SH 45130092015-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
18032568033229Surgical InstrumentsORTHOFIX SRLJDW2026-07-23
18032568033236Surgical InstrumentsORTHOFIX SRLJDW2026-07-23
18032568036008WRIST FIXATION SYSTEMSORTHOFIX SRLJDW2026-07-23
07613327618501HOFFMANN LRFStryker GmbHJDW2026-07-21
08059386747407DOLPHIXCITIEFFE SRLJDW2025-04-02
08052990971893DOLPHIXCITIEFFE SRLJDW2024-10-28
08032909624256ST.A.R. 90 F4CITIEFFE SRLJDW2024-09-11
08905892004599GPCGPC MEDICAL LIMITEDJDW2024-01-31
08905892004605GPCGPC MEDICAL LIMITEDJDW2024-01-31
08905892004612GPCGPC MEDICAL LIMITEDJDW2024-01-31
08905892004629GPCGPC MEDICAL LIMITEDJDW2024-01-31
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08905892004667GPCGPC MEDICAL LIMITEDJDW2024-01-31
08905892004674GPCGPC MEDICAL LIMITEDJDW2024-01-31
08905892004681GPCGPC MEDICAL LIMITEDJDW2024-01-31
08905892004698GPCGPC MEDICAL LIMITEDJDW2024-01-31
08905892004704GPCGPC MEDICAL LIMITEDJDW2024-01-31
08905892004711GPCGPC MEDICAL LIMITEDJDW2024-01-31
08905892004728GPCGPC MEDICAL LIMITEDJDW2024-01-31
08905892004735GPCGPC MEDICAL LIMITEDJDW2024-01-31
08905892004742GPCGPC MEDICAL LIMITEDJDW2024-01-31
08905892004759GPCGPC MEDICAL LIMITEDJDW2024-01-31
08905892004766GPCGPC MEDICAL LIMITEDJDW2024-01-31
08905892004773GPCGPC MEDICAL LIMITEDJDW2024-01-31
08905892004780GPCGPC MEDICAL LIMITEDJDW2024-01-31
08905892004568GPCGPC MEDICAL LIMITEDJDW2023-12-30
08905892004575GPCGPC MEDICAL LIMITEDJDW2023-12-30
08720629950556ANSER Clavicle PinBaat Medical Products B.V.JDW2022-12-14