FDA.reportPublic FDA data

Smart Correction

Primary DI
B5621070009058BA00
Brand
Smart Correction
Company
Wishbone Medical, Inc.
Model
10-700-09058BA-0
Catalog number
10-700-09058BA-0
Device description
Dual Hole Foot Ring Short, 90mm ID, Aluminum, Blue, Non-Sterile
Published
2023-01-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
B5621070009058BA00PrimaryHIBCC0

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
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
062355158
Device count
1
Lot or batch
true
Sterilization required before use
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
07613327616859HOFFMANN LRFStryker GmbHKTT2026-07-23
07613327616880HOFFMANN LRFStryker GmbHKTT2026-07-23
07613327616835HOFFMANN LRFStryker GmbHKTT2026-07-21
07613327616866HOFFMANN LRFStryker GmbHKTT2026-07-21
00889795154620Spider Monkey Bone Transport SystemParagon 28, Inc.KTT2026-06-10
00889795154637Spider Monkey Bone Transport SystemParagon 28, Inc.KTT2026-06-10
00889795154644Spider Monkey Bone Transport SystemParagon 28, Inc.KTT2026-06-10
00889795154651Spider Monkey Bone Transport SystemParagon 28, Inc.KTT2026-06-10
10888867544571Arthrex®ARTHREX, INC.KTT2026-03-13
10886982346872MAXFRAMESynthes GmbHKTT2025-01-29
10886982338778MAXFRAMESYNTHES (U.S.A.) LPKTT2024-02-05
10886982343710MAXFRAMESynthes GmbHKTT2024-01-04
10886982343727MAXFRAMESynthes GmbHKTT2024-01-04
10886982343734MAXFRAMESynthes GmbHKTT2024-01-04
10886982338570MAXFRAMESYNTHES (U.S.A.) LPKTT2022-04-26
10886982338587MAXFRAMESYNTHES (U.S.A.) LPKTT2022-04-26
10886982338594MAXFRAMESYNTHES (U.S.A.) LPKTT2022-04-26
10886982338600MAXFRAMESYNTHES (U.S.A.) LPKTT2022-04-26
00841132142325eZ-FixORTHOPEDIATRICS CORP.KTT2020-02-28
00841132142905eZ-FixORTHOPEDIATRICS CORP.KTT2020-02-28
00841132142950eZ-FixORTHOPEDIATRICS CORP.KTT2020-02-28
00841132143025eZ-FixORTHOPEDIATRICS CORP.KTT2020-02-28
07613327079241HOFFMANNStryker GmbHKTT2018-09-24
07613327079272HOFFMANNStryker GmbHKTT2018-09-24
07613327079333HOFFMANNStryker GmbHKTT2018-09-24
07613327079395HOFFMANNStryker GmbHKTT2018-09-24
07613327079401HOFFMANNStryker GmbHKTT2018-09-24
07613327079449HOFFMANNStryker GmbHKTT2018-09-24
07613327079470HOFFMANNStryker GmbHKTT2018-09-24
07613327079500HOFFMANNStryker GmbHKTT2018-09-24