FDA.reportPublic FDA data

Smart Correction

Primary DI
B56253720000040G0
Brand
Smart Correction
Company
Wishbone Medical, Inc.
Model
53-720-000040G
Device description
Half Pin Cover 4mm (3 pack) – Sterile
Published
2023-03-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B56253720000040G0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
General external orthopaedic fixation system implantation kit, single-useA collection of non-sterile, manual surgical instruments intended to be used for the placement of an external orthopaedic fixation system into or onto all types of bones (e.g., bones of limbs, spine, pelvis, or craniomaxillofacial). It includes various instruments [e.g., retractors, rods, clamps, drills, pins/screws, saws, screwdrivers, guides, trials, impactors] intended to be used for the implantation of any type of external orthopaedic fixation system (i.e., non-dedicated); it does not include any implantable devices. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(574) 306-4006WeCare@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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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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00198506091070ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
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