FDA.reportPublic FDA data

DRACO

Primary DI
00841742143439
Brand
DRACO
Company
HNM TOTAL RECON LLC
Model
HTR-03-040130T
Catalog number
HTR-03-040130T
Device description
DRACO ø4.3mm Cannnulated Headless Compression Screw, Partially Thread, Ti - (L)30mm, Torx
Published
2018-04-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
K152187000
K171628000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152187000MetaFix LS Locking Screws, Merete Cannulated PCS, Merete CS Cortical Screws, Merete Cannulated HCS, DuoThread Scarf Screws and TwistCut Snap-Off ScrewsMerete Medical GmbH2016-02-12HWC
K171628000HBS2 Headless Bone ScrewStuckenbrock Medizintechnik GmbH2018-01-12HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841742143439PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841742143439008417421434398417421434390841742143439

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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
080024940
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841742143774ORIONHTR-04-304812HTR-04-3048122020-11-18
00841742143781ORIONHTR-04-304914HTR-04-3049142020-11-18
00841742143798ORIONHTR-04-304116HTR-04-3041162020-11-18
00841742143804ORIONHTR-04-304218HTR-04-3042182020-11-18
00841742143811ORIONHTR-04-304320HTR-04-3043202020-11-18
00841742143828ORIONHTR-04-304422HTR-04-3044222020-11-18
00841742143835ORIONHTR-04-304524HTR-04-3045242020-11-18
00841742143842ORIONHTR-04-304626HTR-04-3046262020-11-18
00841742143859ORIONHTR-04-304728HTR-04-3047282020-11-18
00841742143866ORIONHTR-04-304830HTR-04-3048302020-11-18
00841742143873ORIONHTR-04-304932HTR-04-3049322020-11-18
00841742143880ORIONHTR-04-304134HTR-04-3041342020-11-18
00841742143897ORIONHTR-04-304236HTR-04-3042362020-11-18
00841742143903ORIONHTR-04-304338HTR-04-3043382020-11-18
00841742143910ORIONHTR-04-304440HTR-04-3044402020-11-18
00841742143927ORIONHTR-04-404514HTR-04-4045142020-11-18
00841742143934ORIONHTR-04-404616HTR-04-4046162020-11-18
00841742143941ORIONHTR-04-404718HTR-04-4047182020-11-18
00841742143958ORIONHTR-04-404820HTR-04-4048202020-11-18
00841742143965ORIONHTR-04-404922HTR-04-4049222020-11-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842188131615CannCompScrew 5.5 (Ti)Trimed, INC.HWC2026-09-25
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00842188131653CannCompScrew 5.5 (Ti)Trimed, INC.HWC2026-09-25
00842188131677CannCompScrew 5.5 (Ti)Trimed, INC.HWC2026-09-25
00842188131721CannCompScrew 5.5 (Ti)Trimed, INC.HWC2026-09-25
00889095401820ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095401844ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095401868ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095401882ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095401905ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095401929ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
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00889095402438ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095402483ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
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00889095411287ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095411300ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095411324ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095611274ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
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