FDA.reportPublic FDA data

Smart Correction

Primary DI
B5621070012018RA00
Brand
Smart Correction
Company
Wishbone Medical, Inc.
Model
10-700-12018RA-0
Catalog number
10-700-12018RA-0
Device description
Dual Hole 1/2 Ring, 120mm ID, Aluminum, Red, 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
B5621070012018RA00PrimaryHIBCC0

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
B562PK301ELB1600K-WirePK-301-ELB1602023-03-16
B562PK301ELB2000K-WirePK-301-ELB2002023-03-16
B562PK301EXT1250K-WirePK-301-ELB2002023-03-16
B56213904001220S00WishBone K-Wire System13-904-001220S-013-904-001220S-02022-07-18
B56213904001220S10WishBone K-Wire System13-904-001220S-113-904-001220S-12022-07-18
B56213904001620S00WishBone K-Wire System13-904-001620S-013-904-001620S-02022-07-18
B56213904001620S10WishBone K-Wire System13-904-001620S-113-904-001620S-12022-07-18
B56213904002020S00WishBone K-Wire System13-904-002020S-013-904-002020S-02022-07-18
B56213904002020S10WishBone K-Wire System13-904-002020S-113-904-002020S-12022-07-18
B56213904002520S00WishBone K-Wire System13-904-002520S-013-904-002520S-02022-07-18
B56213904002520S10WishBone K-Wire System13-904-002520S-113-904-002520S-12022-07-18
B562PKKWELB0WishBone K-Wire SystemPK-KWELBPK-KWELB2020-12-02
B562PKKWELBUS0WishBone K-Wire SystemPK-KWELB-USPK-KWELB2020-12-02
B562PKKWEXT0WishBone K-Wire SystemPK-KWEXTPK-KWEXT2020-12-02
B562PKKWEXTUS0WishBone K-Wire SystemPK-KWEXT-USPK-KWEXT2020-12-02
B562KITKWIEXSML0Pediatric Extremity Combo K-Wire System-SMALLKIT-KWI-EXSML2019-03-28
B562KITKWIELBOW0Pediatric Elbow Combo K-Wire SystemKIT-KWI-ELBOW2019-03-18
B562KITKWIEXLAR0Pediatric Extremity Combo K-Wire SystemKIT-KWI-EXLAR2019-03-19
B562KITKWIEXMED0Pediatric Extremity Combo K-Wire SystemKIT-KWI-EXMED2019-03-19
B562KITKWILBONE0Pediatric Long Bone Combo K-Wire SystemKIT-KWI-LBONE2019-03-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08903993241486130° Wise-Lock DHS Plate, 2 Holes, Stainless SteelAuxein Medical Private LimitedKTT2026-04-18
08903993241493130° Wise-Lock DHS Plate, 3 Holes, Stainless SteelAuxein Medical Private LimitedKTT2026-04-18
08032909626380ST.A.R. 90 F4CITIEFFE SRLKTT2026-03-17
08051739535730ST.A.R. 90 F4CITIEFFE SRLKTT2026-03-10
08059386747391DOLPHIXCITIEFFE SRLKTT2025-04-02
10080196692729MEDLINEMEDLINE INDUSTRIES, INC.KTT2025-01-29
10080196692866MEDLINEMEDLINE INDUSTRIES, INC.KTT2025-01-29
08032909624263ST.A.R. 90 F4CITIEFFE SRLKTT2024-09-11
08032909624270ST.A.R. 90 F4CITIEFFE SRLKTT2024-09-11
08032909624317ST.A.R. 90 F4CITIEFFE SRLKTT2024-07-19
08032909624355ST.A.R. 90 F4CITIEFFE SRLKTT2024-07-19
08032909624362ST.A.R. 90 F4CITIEFFE SRLKTT2024-07-19
10886982338778MAXFRAMESYNTHES (U.S.A.) LPKTT2024-02-05
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
08032909627639DOLPHIXCITIEFFE SRLKTT2020-01-10
08052990974535DOLPHIXCITIEFFE SRLKTT2020-01-10
08051739536225ST.A.R. 90 F4CITIEFFE SRLKTT2019-11-29
08051739531244DOLPHIXCITIEFFE SRLKTT2019-05-18
08052990972661DOLPHIXCITIEFFE SRLKTT2019-05-18
08052990974542DOLPHIXCITIEFFE SRLKTT2019-05-18
08052990974566DOLPHIXCITIEFFE SRLKTT2019-05-18
08051739531725DOLPHIXCITIEFFE SRLKTT2019-01-09
08051739531732DOLPHIXCITIEFFE SRLKTT2019-01-09
08051739531749DOLPHIXCITIEFFE SRLKTT2019-01-09
08051739531756DOLPHIXCITIEFFE SRLKTT2018-12-15
08051739531763DOLPHIXCITIEFFE SRLKTT2018-12-15
08051739531770DOLPHIXCITIEFFE SRLKTT2018-12-15