FDA.reportPublic FDA data

WishBone Plate & Screw System

Primary DI
B56251201WR0070T00
Brand
WishBone Plate & Screw System
Company
Wishbone Medical, Inc.
Model
51-201-WR0070T-0
Catalog number
51-201-WR0070T-0
Device description
7.0 Washer, Ti
Published
2022-07-18
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

Product Codes#

Code, Name table
CodeName
HTNWasher, Bolt Nut

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTNWasher, Bolt NutOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K203467000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203467000WishBone Medical Plate and Screw SystemWishbone Medical, Inc.2020-12-23HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B56251201WR0070T00PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone washer, sterileA sterile flat thin ring or plate designed to be used with a nut and bolt/screw to improve tightness in an orthopaedic fixation assembly. It may be made of metal, polymer, or reinforced polymer. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
062355158
Device count
1
Lot or batch
true
Manufacturing date on label
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
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00850080543016PC Fix Locking Cap TiChest Wall Innovations, Inc.HTN2026-06-01
00850080543023PC Fix Washer TiChest Wall Innovations, Inc.HTN2026-06-01
00850080543030PC Fix Extrathoracic Plate 70mm TiChest Wall Innovations, Inc.HTN2026-06-01
00850080543047PC Fix Extrathoracic Plate 95mm TiChest Wall Innovations, Inc.HTN2026-06-01
00850080543054PC Fix Intrathoracic Plate 70mm TiChest Wall Innovations, Inc.HTN2026-06-01
00850080543061PC Fix Intrathoracic Plate 95mm TiChest Wall Innovations, Inc.HTN2026-06-01
00850080543078PC Fix Thoracic Plate 70mm PEEKChest Wall Innovations, Inc.HTN2026-06-01
00850080543085PC Fix Thoracic Plate 95mm PEEKChest Wall Innovations, Inc.HTN2026-06-01
00850080543092PC Fix 3.2mm Drill Brad Point QCChest Wall Innovations, Inc.HTN2026-06-01
00850080543108PC Fix Graphic CaseChest Wall Innovations, Inc.HTN2026-06-01
00850080543115PC Fix Clamp/Drill Guide TopChest Wall Innovations, Inc.HTN2026-06-01
00850080543122PC Fix Clamp/Drill Guide BottomChest Wall Innovations, Inc.HTN2026-06-01
00850080543139PC Fix Compression ClampChest Wall Innovations, Inc.HTN2026-06-01
00850080543146PC Fix 3.2mm Drill Dental LatchChest Wall Innovations, Inc.HTN2026-06-01
00850080543184PC Fix Implant CaddyChest Wall Innovations, Inc.HTN2026-06-01
07901125602533Expert KnotlessGM DOS REIS INDUSTRIA E COMERCIO LTDAHTN2026-05-28
00888867251960Arthrex®ARTHREX, INC.HTN2017-11-28
00888867196537Arthrex®ARTHREX, INC.HTN2017-05-11
00888867196582Arthrex®ARTHREX, INC.HTN2017-05-11
00888867251939Arthrex®ARTHREX, INC.HTN2017-02-15
10845854015506CONMEDConmed CorporationHTN2015-12-10
10845854015865CONMEDConmed CorporationHTN2015-12-10
10845854015957CONMEDConmed CorporationHTN2015-12-10
10845854015698CONMEDConmed CorporationHTN2015-12-10
10845854015872CONMEDConmed CorporationHTN2015-12-10
07613327075830ASNISStryker GmbHHTN2015-11-11
07613327076189ASNISStryker GmbHHTN2015-11-11
07613327076301ASNISStryker GmbHHTN2015-11-11
07613327076554ASNISStryker GmbHHTN2015-11-11