FDA.reportPublic FDA data

K-Wire

Primary DI
B562PK301ELB1600
Brand
K-Wire
Company
Wishbone Medical, Inc.
Model
PK-301-ELB160
Device description
Elbow Fracture Kit - 1.60mm
Published
2023-03-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
B562PK301ELB1600PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Spinal bone screw, non-bioabsorbableA small, threaded rod with a slotted head intended to be used for internal spinal fixation by being screwed into the spine to hold a stabilization device (e.g., rod, plate) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is available in various types, including pedicle and transfacet, and is typically used to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(574) 306-4006WeCare@WishBoneMedical.com

Regulatory Flags#

DUNS number
062355158
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B56211113030006S10PRIMA Proximal Femur Locking Plate System11-113-030006S-12023-04-12
B56211113030012S10PRIMA Proximal Femur Locking Plate System11-113-030012S-12023-04-12
B56211113040006S10PRIMA Proximal Femur Locking Plate System11-114-040006S-12023-04-12
B56211113040014S10PRIMA Proximal Femur Locking Plate System11-114-040014S-12023-04-12
B56211113130006S10PRIMA Proximal Femur Locking Plate System11-113-130006S-12023-04-12
B56211113130012S10PRIMA Proximal Femur Locking Plate System11-113-130012S-12023-04-12
B56211113140006S10PRIMA Proximal Femur Locking Plate System11-114-140006S-12023-04-12
B56211113140014S10PRIMA Proximal Femur Locking Plate System11-114-140014S-12023-04-12
B56211113301800S10PRIMA Proximal Femur Locking Plate System11-113-301800S-12023-04-12
B56211113331800S01PRIMA Proximal Femur Locking Plate System11-113-331800S-12023-04-12
B56211113331800S10PRIMA Proximal Femur Locking Plate System11-114-331800S-12023-04-12
B56211113341800S10PRIMA Proximal Femur Locking Plate System11-113-341800S-12023-04-12
B56211113361800S10PRIMA Proximal Femur Locking Plate System11-113-361800S-12023-04-12
B56211113381800S10PRIMA Proximal Femur Locking Plate System11-113-381800S-12023-04-12
B56211113431800S10PRIMA Proximal Femur Locking Plate System11-113-431800S-12023-04-12
B56211113441800S10PRIMA Proximal Femur Locking Plate System11-114-441800S-12023-04-12
B56211113930006S10PRIMA Proximal Femur Locking Plate System11-113-930006S-12023-04-12
B56211113930012S10PRIMA Proximal Femur Locking Plate System11-113-930012S-12023-04-12
B56211113930014S10PRIMA Proximal Femur Locking Plate System11-114-930014S-12023-04-12
B56211114301800S10PRIMA Proximal Femur Locking Plate System11-114-301800S-12023-04-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776403928MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776403935MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436025MillenniumAvalign Technologies, Inc.HTY2026-07-22
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
00190776436117MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436124MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436131MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436148MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776403775MillenniumAvalign Technologies, Inc.HTY2026-07-21
00190776403850MillenniumAvalign Technologies, Inc.HTY2026-07-21
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07630894830822APTUSMedartis AGHTY2026-06-01
07630894830839APTUSMedartis AGHTY2026-06-01
07630894830884APTUSMedartis AGHTY2026-06-01
07630894830891APTUSMedartis AGHTY2026-06-01
10888867544571Arthrex®ARTHREX, INC.HTY2026-03-13
07649990202419Drill S-PI-A1.6 extra shortSurgical Fusion Technologies GmbHHTY2026-01-18
07649990202174Geomax Reamer S-PI-A1.6Surgical Fusion Technologies GmbHHTY2025-10-01
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