FDA.reportPublic FDA data

K-Wire

Primary DI
B562PK301ELB2000
Brand
K-Wire
Company
Wishbone Medical, Inc.
Model
PK-301-ELB200
Device description
Elbow Fracture Kit - 2.00mm
Published
2023-03-16
Public version status
Update
Distribution status
Not 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
HTYPin, Fixation, Smooth

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTYPin, Fixation, SmoothOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K173013000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173013000WishBone K-Wire SystemWishbone Medical, Inc.2017-12-14HTY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B562PK301ELB2000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Spinal bone screw, non-bioabsorbableA small, threaded, implantable rod with a screw head and drive intended for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (e.g., surgical steel, titanium alloy, carbon fibre). It is available in various types (e.g., pedicle or transfacet, with a slotted, cross, star, or polygonal drive), and is typically used to provide immobilization and stabilization of spinal segments in the treatment of spinal instabilities or deformities. A screw head adaptor intended to stabilize a rod may be included with the screw.

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
true
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
B562PKBVF050WISHBONE MGPK-BVF052020-07-01
B562PKBVF100WISHBONE MGPK-BVF102020-07-01
B562PKBVF150WISHBONE MGPK-BVF152020-07-01
B562PKGS000100Micro Surgery KitPK-GS0001PK-GS00012024-12-30
B562PKGS000200Minor Surgery KitPK-GS0002PK-GS00022024-12-30
B562PK301ELB1600K-WirePK-301-ELB1602023-03-16
B562PK301EXT1250K-WirePK-301-ELB2002023-03-16
B562PKEFC0416S080WishFIXPK-EFC0416S-082023-03-16
B562PKOCD02010AlloMatePK-OCD020-12023-03-16
B562PKOCD02510AlloMatePK-OCD025-12023-03-16
B562PKOCD03010AlloMatePK-OCD030-12023-03-16
B562PKOCD03510AlloMatePK-OCD035-12023-03-16
B562PKOCD04010AlloMatePK-OCD040-12023-03-16
B562066582BWB0Sterile Spine Pedicle Screw System06.6582B-WB06.6582B-WB2022-07-19
B562066587BWB0Sterile Spine Pedicle Screw System06.6587B-WB06.6587B-WB2022-07-19
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05055662968538Volition™ Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDHTY2026-10-16
09353903004240FO NX Nail SystemFIELD ORTHOPAEDICS PTY LTDHTY2026-10-12
09353903004257FO NX Nail SystemFIELD ORTHOPAEDICS PTY LTDHTY2026-10-12
M791TPK1237HTA0Traction Pin KitBIOACCESS INCHTY2026-09-04
M791TPK1253HTA0Traction Pin KitBIOACCESS INCHTY2026-09-04
00840536824974PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00840536824981PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00840536824998PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00840536825001PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00840536825018PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00840536825025PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00840536825032PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00840536825049PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00840536825056PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00840536825063PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00840536825070PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00840536825087PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00840536825094PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00190776405960MillenniumAvalign Technologies, Inc.HTY2026-07-28
00190776403928MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776403935MillenniumAvalign Technologies, Inc.HTY2026-07-22
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00190776436032MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436049MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436056MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436063MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436070MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436087MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436094MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436100MillenniumAvalign Technologies, Inc.HTY2026-07-22