FDA.reportPublic FDA data

Smart Correction

Primary DI
B5621070024006BA00
Brand
Smart Correction
Company
WISHBONE MEDICAL, INC.
Model
10-700-24006BA-0
Catalog number
10-700-24006BA-0
Device description
Dual Hole Full Ring, 240mm ID, Aluminum, Blue, Non-Sterile
Published
2023-02-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B5621070024006BA00PrimaryHIBCC0

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
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
(574) 306-4006CustomerService@wishbonemedical.com

Regulatory Flags#

DUNS number
062355158
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
true
Expiration date on label
false
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
B562PKGS000100Micro Surgery KitPK-GS0001PK-GS00012024-12-30
B562PKGS000200Minor Surgery KitPK-GS0002PK-GS00022024-12-30
B56251300MDG000G10WishBone Plate & Screw System51-300-MDG000G-151-300-MDG000G-12024-01-01
B56211705310200S0Smart Correction11-705-310200S11-705-310200S2023-06-23
B56211705315200S0Smart Correction11-705-315200S11-705-315200S2023-06-23
B56211705320200S0Smart Correction11-705-320200S11-705-320200S2023-06-23
B56211705325200S0Smart Correction11-705-325200S11-705-325200S2023-06-23
B56211705330200S0Smart Correction11-705-330200S11-705-330200S2023-06-23
B56211705335200S0Smart Correction11-705-335200S11-705-335200S2023-06-23
B56211705340200S0Smart Correction11-705-340200S11-705-340200S2023-06-23
B56211705345200S0Smart Correction11-705-345200S11-705-345200S2023-06-23
B56211705350200S0Smart Correction11-705-350200S11-705-350200S2023-06-23
B56211705410200S0Smart Correction11-705-410200S11-705-410200S2023-06-23
B56211705415200S0Smart Correction11-705-415200S11-705-415200S2023-06-23
B56211705420200S0Smart Correction11-705-420200S11-705-420200S2023-06-23
B56211705425200S0Smart Correction11-705-425200S11-705-425200S2023-06-23
B56211705430200S0Smart Correction11-705-430200S11-705-430200S2023-06-23
B56211705435200S0Smart Correction11-705-435200S11-705-435200S2023-06-23
B56211705440200S0Smart Correction11-705-440200S11-705-440200S2023-06-23
B56211705445200S0Smart Correction11-705-445200S11-705-445200S2023-06-23

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Primary DI, Brand, Company table
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00888867543355Arthrex®ARTHREX, INC.KTT2026-03-13
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00888867543638Arthrex®ARTHREX, INC.KTT2026-03-13
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00888867543676Arthrex®ARTHREX, INC.KTT2026-03-13
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00888867543706Arthrex®ARTHREX, INC.KTT2026-03-13
00888867543713Arthrex®ARTHREX, INC.KTT2026-03-13
00888867543799Arthrex®ARTHREX, INC.KTT2026-03-13
00888867543843Arthrex®ARTHREX, INC.KTT2026-03-13
00888867543881Arthrex®ARTHREX, INC.KTT2026-03-13
00841731149077DYNEX MICROVILEX LLCKTT2026-03-03
00889795151827The Brachiator Mini External Fixation SystemParagon 28, Inc.KTT2025-12-16
00889795151834The Brachiator Mini External Fixation SystemParagon 28, Inc.KTT2025-12-16
00889795151841The Brachiator Mini External Fixation SystemParagon 28, Inc.KTT2025-12-16
00889795151858The Brachiator Mini External Fixation SystemParagon 28, Inc.KTT2025-12-16