FDA.reportPublic FDA data

4.5mm Locking Screw for Tibial Nail

Primary DI
06942782413897
Brand
4.5mm Locking Screw for Tibial Nail
Company
Double Medical Technology Inc.
Model
070070045
Catalog number
070070045
Published
2016-09-01
Public version status
Update
Distribution status
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
HSBRod, Fixation, Intramedullary And Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSBRod, Fixation, Intramedullary And AccessoriesOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K131609000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131609000DOUBLE ENGINE INTRAMEDDULLARY NAIL SYSTEMXiamen Double Engine Medical Material Co., Ltd.2014-05-21HSB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06942782413897PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06942782413897069427824138976942782413897

GMDN Terms#

Term, Definition table
TermDefinition
Tibia nail, non-sterileA non-sterile rod made of metal or other material which, when inserted into the intramedullary canal of the tibia, acts to immobilize by holding the ends of a fractured bone in position to promote healing. The device may also be used to support the bone in the presence of a pathological condition, or for knee arthrodesis. The device may be a locked or unlocked model, and possess components to assist fixation of more proximal or distal conditions. This is a single-use device intended to be sterilized prior to use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length45Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+865926087101info@double-medical.com

Regulatory Flags#

DUNS number
529366055
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06942782416232Universal End Cap for PFN/UFN/UTN0700800000700800002016-09-01
06942782448479End Cap for Universal Tibial Nail II0712800000712800002016-09-01
06942782448486End Cap for Universal Tibial Nail II0712800050712800052016-09-01
06942782448493End Cap for Universal Tibial Nail II0712800100712800102016-09-01
06942782448509End Cap for Universal Tibial Nail II0712800150712800152016-09-01
06902139001320Clavicular Hook Locking Plate I0200410090200410092016-09-01
06902139001337Clavicular Hook Locking Plate I0200410100200410102016-09-01
06902139001344Clavicular Hook Locking Plate I0200410110200410112016-09-01
06902139001351Clavicular Hook Locking Plate I0200420090200420092016-09-01
06902139001368Clavicular Hook Locking Plate I0200420100200420102016-09-01
06902139001375Clavicular Hook Locking Plate I0200420110200420112016-09-01
06902139001382Distal Lateral Tibial Locking Plate0201910140201910142016-09-01
06902139001399Distal Lateral Tibial Locking Plate0201910160201910162016-09-01
06902139001405Distal Lateral Tibial Locking Plate0201920140201920142016-09-01
06902139001412Narrow Limited Contact Locking Plate, Combi-holes0204100170204100172016-09-01
06902139001429Ulnar Hook Locking Plate I0213400070213400072016-09-01
06902139001436Distal Medial Tibial Locking Plate III0214910030214910032016-09-01
06902139001443Distal Medial Tibial Locking Plate III0214910040214910042016-09-01
06902139001450Distal Medial Tibial Locking Plate III0214910050214910052016-09-01
06902139001467Distal Medial Tibial Locking Plate III0214910070214910072016-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00193982660147AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-06-10
00193982660161AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-06-10
00193982660185AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-06-10
00193982660208AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-06-10
00193982660222AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-06-10
00193982660246AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-06-10
00193982660260AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-06-10
00193982660284AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-06-10
00193982660307AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-06-10
00193982660321AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-06-10
B058AHN08165L1Atlas™ Humeral Nail SystemOrthopedic Designs North America, Inc.HSB2026-05-29
B058AHN08165R1Atlas™ Humeral Nail SystemOrthopedic Designs North America, Inc.HSB2026-05-29
10855068008423Lock ActivatorCURVAFIX, INC.HSB2022-06-20
10855068008492Inserter/ExtractorCURVAFIX, INC.HSB2022-06-20
10855068008539Sterilization Case, OuterCURVAFIX, INC.HSB2022-06-20
10855068008621Ring Lock, Long InserterCURVAFIX, INC.HSB2022-06-20
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