FDA.reportPublic FDA data

Quick-Start

Primary DI
05060464140327
Brand
Quick-Start
Company
INNOVATE ORTHOPAEDICS LIMITED
Model
10025
Catalog number
10025
Device description
Quick-Start Guide-wire 1.8mm x 250mm
Published
2022-07-15
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
HWCScrew, Fixation, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWCScrew, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K212547000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212547000Quick-Start ScrewsInnovate Orthopaedics Limited2021-12-30HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060464140259PrimaryGS10
05060464140327Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060464140259050604641402595060464140259
05060464140327050604641403275060464140327

GMDN Terms#

Term, Definition table
TermDefinition
Bone nail guidewire, single-useA sterile, long, thin, metal rod designed to guide intramedullary canal devices for performing the implantation of an intramedullary nail to treat damaged bone. The rod is usually manually inserted into the canal to typically guide a surgical instrument (e.g., a reamer) and the implantable nail. This device is made of metal [e.g., high-grade stainless steel, titanium (Ti)] and is available in a variety of sizes, lengths, and designs (e.g., round-tip, trocar-tip, or flexible-tip). It may be used in femoral, tibial, humeral or supracondylar intramedullary canals. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(508) 618-1337enquiries@xirosna.com

Regulatory Flags#

DUNS number
220348521
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060464140013Quick-Start10001100012022-07-15
05060464140020Quick-Start10002100022022-07-15
05060464140037Quick-Start10003100032022-07-15
05060464140044Quick-Start10004100042022-07-15
05060464140051Quick-Start10005100052022-07-15
05060464140068Quick-Start10006100062022-07-15
05060464140075Quick-Start10007100072022-07-15
05060464140082Quick-Start10008100082022-07-15
05060464140099Quick-Start10009100092022-07-15
05060464140105Quick-Start10010100102022-07-15
05060464140112Quick-Start10011100112022-07-15
05060464140129Quick-Start10012100122022-07-15
05060464140136Quick-Start10013100132022-07-15
05060464140143Quick-Start10014100142022-07-15
05060464140150Quick-Start10015100152022-07-15
05060464140167Quick-Start10016100162022-07-15
05060464140174Quick-Start10017100172022-07-15
05060464140181Quick-Start10018100182022-07-15
05060464140198Quick-Start10019100192022-07-15
05060464140204Quick-Start10020100202022-07-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842078100004HammerFiXEXTREMITY MEDICAL, LLCHWC2026-10-29
00842078100011HammerFiXEXTREMITY MEDICAL, LLCHWC2026-10-29
00842078100028HammerFiXEXTREMITY MEDICAL, LLCHWC2026-10-29
00842078100035HammerFiXEXTREMITY MEDICAL, LLCHWC2026-10-29
20810152101418DYNAMIS™ Implant SystemPromethean Restorative, Inc.HWC2025-06-13
20810152101425DYNAMIS™ Implant SystemPromethean Restorative, Inc.HWC2025-06-13
20810152101432DYNAMIS™ Implant SystemPromethean Restorative, Inc.HWC2025-06-13
20810152101449DYNAMIS™ Implant SystemPromethean Restorative, Inc.HWC2025-06-13
20810152101456DYNAMIS™ Implant SystemPromethean Restorative, Inc.HWC2025-06-13
20810152101463DYNAMIS™ Implant SystemPromethean Restorative, Inc.HWC2025-06-13
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20810152101494DYNAMIS™ Implant SystemPromethean Restorative, Inc.HWC2025-06-13
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20810152101579DYNAMIS™ Implant SystemPromethean Restorative, Inc.HWC2025-06-13
20810152101586DYNAMIS™ Implant SystemPromethean Restorative, Inc.HWC2025-06-13
20810152101593DYNAMIS™ Implant SystemPromethean Restorative, Inc.HWC2025-06-13
20810152101609DYNAMIS™ Implant SystemPromethean Restorative, Inc.HWC2025-06-13
20810152101616DYNAMIS™ Implant SystemPromethean Restorative, Inc.HWC2025-06-13
20810152101623DYNAMIS™ Implant SystemPromethean Restorative, Inc.HWC2025-06-13
20810152101630DYNAMIS™ Implant SystemPromethean Restorative, Inc.HWC2025-06-13
20810152101647DYNAMIS™ Implant SystemPromethean Restorative, Inc.HWC2025-06-13
20810152101654DYNAMIS™ Implant SystemPromethean Restorative, Inc.HWC2025-06-13
20810152101661DYNAMIS™ Implant SystemPromethean Restorative, Inc.HWC2025-06-13