FDA.reportPublic FDA data

BITE COMPRESSION SCREWS

Primary DI
18056099643191
Brand
BITE COMPRESSION SCREWS
Company
ORTHOFIX SRL
Model
1
Catalog number
001-C-35014
Device description
LOW PROFILE HEADED COMPRESSION SCREW, D 3.5MM X 14MM
Published
2017-06-20
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
K132893000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132893000EDGE ORTHOPAEDICS BITE COMPRESSION SCREWIcon Orthopaedic Concepts Dba Edge Orthopaedics2013-11-20HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18056099643191PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1805609964319118056099643191

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw, non-bioabsorbable, sterileA small, 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). There are a number of kinds available: 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 across bone fragments.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length14Millimeter
Outer Diameter3.5Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+0390456719000info@orthofix.it

Regulatory Flags#

DUNS number
438793622
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
18032568033229Surgical Instruments1136202026-07-23
18032568033236Surgical Instruments1136212026-07-23
18032568036008WRIST FIXATION SYSTEMS1360082026-07-23
18059015376838Fitbone Transport and Lengthening System199-600038172026-07-23
18059015376845Fitbone Transport and Lengthening System199-600038182026-07-23
18059015376852Fitbone Transport and Lengthening System199-600038192026-07-23
18059015376869Fitbone Transport and Lengthening System199-600038202026-07-23
18059015376876Fitbone Transport and Lengthening System199-600038212026-07-23
18059015376883Fitbone Transport and Lengthening System199-600038222026-07-23
18059015376890Fitbone Transport and Lengthening System199-600038232026-07-23
18059015376906Fitbone Transport and Lengthening System199-600038242026-07-23
18059015376913Fitbone Transport and Lengthening System199-600038252026-07-23
18059015376920Fitbone Transport and Lengthening System199-600038262026-07-23
18059015376937Fitbone Transport and Lengthening System199-600038272026-07-23
18059015376944Fitbone Transport and Lengthening System199-600038282026-07-23
18059015376951Fitbone Transport and Lengthening System199-600038292026-07-23
18059015376968Fitbone Transport and Lengthening System199-600038302026-07-23
18059015376975Fitbone Transport and Lengthening System199-600038312026-07-23
18059015376982Fitbone Transport and Lengthening System199-600038322026-07-23
18059015376999Fitbone Transport and Lengthening System199-600038332026-07-23

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Primary DI, Brand, Company table
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00841731140524ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140531ARTEMIS FUZEVILEX LLCHWC2026-07-22
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00841731140623ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140630ARTEMIS FUZEVILEX LLCHWC2026-07-22
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00841731140661ARTEMIS FUZEVILEX LLCHWC2026-07-22
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00841731140685ARTEMIS FUZEVILEX LLCHWC2026-07-22