FDA.reportPublic FDA data

Smart Correction

Primary DI
B56211701360180S00
Brand
Smart Correction
Company
Wishbone Medical, Inc.
Model
11-701-360180S-0
Catalog number
11-701-360180S-0
Device description
HA Half Pin, 6mm, 180X50, Self Drilling
Published
2022-07-20
Public version status
Update
Distribution status
Not 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
K150661000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150661000ST.A.R. 90 F4 External Fixation Screws With HydroxyapatiteCitieffe S.R.L.2015-07-07JDW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B56211701360180S00PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
External orthopaedic fixation system, single-useAn assembly of devices designed to stabilize fractured bones to promote treatment and healing. It typically consists of an external plastic and/or metallic fixator (a framework) and other external and/or implantable components such as clamps, rods, rings, pins, bolts, and nuts, as well as some reusable instrumentation (e.g., wrenches, depth gauge, tensioner). It is used mainly to help the healing of long bones such as the femur, tibia and humerus, as well as fractures of the foot and ankle, joint fusions, and limb lengthening. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
062355158
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
B56251300MDG000G10WishBone Plate & Screw System51-300-MDG000G-151-300-MDG000G-12024-01-01
B562TCX27008US02.7mm x 8mm Ti Cortical ScrewTCX27008-USTCX270082019-11-25
B562TCX27010US02.7mm x 10mm Ti Cortical ScrewTCX27010-USTCX270102019-11-25
B562TCX27012US02.7mm x 12mm Ti Cortical ScrewTCX27012-USTCX270122019-11-25
B562TCX27014US02.7mm x 14mm Ti Cortical ScrewTCX27014-USTCX270142019-11-25
B562TCX27016US02.7mm x 16mm Ti Cortical ScrewTCX27016-USTCX270162019-11-25
B562TCX27018US02.7mm x 18mm Ti Cortical ScrewTCX27018-USTCX270182019-11-25
B562TCX27020US02.7mm x 20mm Ti Cortical ScrewTCX27020-USTCX270202019-11-25
B562TCX27022US02.7mm x 22mm Ti Cortical ScrewTCX27022-USTCX270222019-11-25
B562TCX27024US02.7mm x 24mm Ti Cortical ScrewTCX27024-USTCX270242019-11-25
B562TCX27026US02.7mm x 26mm Ti Cortical ScrewTCX27026-USTCX270262019-11-25
B562TCX27028US02.7mm x 28mm Ti Cortical ScrewTCX27028-USTCX270282019-11-25
B562TCX27030US02.7mm x 30mm Ti Cortical ScrewTCX27030-USTCX270302019-11-25
B562TCX27032US02.7mm x 32mm Ti Cortical ScrewTCX27032-USTCX270322019-11-25
B562TCX27034US02.7mm x 34mm Ti Cortical ScrewTCX27034-USTCX270342019-11-25
B562TCX27036US02.7mm x 36mm Ti Cortical ScrewTCX27036-USTCX270362019-11-25
B562TCX27038US02.7mm x 38mm Ti Cortical ScrewTCX27038-USTCX270382019-11-25
B562TCX27040US02.7mm x 40mm Ti Cortical ScrewTCX27040-USTCX270402019-11-25
B562TCX27045US02.7mm x 45mm Ti Cortical ScrewTCX27045-USTCX270452019-11-25
B562TCX27050US02.7mm x 50mm Ti Cortical ScrewTCX27050-USTCX270502019-11-25

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
08905892004636GPCGPC MEDICAL LIMITEDJDW2024-01-31
08905892004643GPCGPC MEDICAL LIMITEDJDW2024-01-31
08905892004650GPCGPC MEDICAL LIMITEDJDW2024-01-31
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