FDA.reportPublic FDA data

ORION

Primary DI
00841742143873
Brand
ORION
Company
HNM TOTAL RECON LLC
Model
HTR-04-304932
Catalog number
HTR-04-304932
Device description
ORION ø3.0mm Headed Cannulated Screw, Long Thread, Ti - (L)32mm
Published
2020-11-18
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
K153575000
K171628000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K153575000Tyber Medical Trauma ScrewTyber Medical, LLC2016-02-26HWC
K171628000HBS2 Headless Bone ScrewStuckenbrock Medizintechnik GmbH2018-01-12HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841742143873PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841742143873008417421438738417421438730841742143873

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
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
00841742143972ORIONHTR-04-404124HTR-04-4041242020-11-18

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