FDA.reportPublic FDA data

3.0mm Heberden Screw

Primary DI
06942782410087
Brand
3.0mm Heberden Screw
Company
Double Medical Technology Inc.
Model
060010028
Catalog number
060010028
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
HRSPlate, Fixation, Bone
HWCScrew, Fixation, Bone

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K130108000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130108000DOUBLE ENGINE BONE PLATE AND SCREW SYSTEMSXiamen Double Engine Medical Material Co., Ltd.2013-04-19HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06942782410087PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06942782410087069427824100876942782410087

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw, non-bioabsorbable, non-sterileA small, non-sterile, threaded rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that cannot be chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). Screws available are: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded, self-tapping, and cannulated. A "lag screw" can be any of these used to obtain compression. This device must be sterilized prior to use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Length28Millimeter

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

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