FDA.reportPublic FDA data

Vilex Lag Screw, FT

Primary DI
00841731106926
Brand
Vilex Lag Screw, FT
Company
VILEX LLC
Model
FT25-15S-11
Device description
Screw, Fully Thrd. 2.5x15mm SS
Published
2016-08-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
K973309000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K973309000VILEX CANNULATED BONE SCREW, DUVAL CANNULATED BONE SCREWVilex, Inc.1998-01-16HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841731106926PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841731106926008417311069268417311069260841731106926

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
117502293
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841731147431OPTIXOX2-0011OX2-00112026-03-03
00841731140395ARTEMIS FUZEAV40-20T-16V2026-07-22
00841731140401ARTEMIS FUZEAV40-22T-16V2026-07-22
00841731140418ARTEMIS FUZEAV40-24T-16V2026-07-22
00841731140425ARTEMIS FUZEAV40-26T-16V2026-07-22
00841731140432ARTEMIS FUZEAV40-28T-16V2026-07-22
00841731140449ARTEMIS FUZEAV40-30T-16V2026-07-22
00841731140456ARTEMIS FUZEAV40-32T-16V2026-07-22
00841731140463ARTEMIS FUZEAV40-34T-16V2026-07-22
00841731140470ARTEMIS FUZEAV40-36T-16V2026-07-22
00841731140487ARTEMIS FUZEAV40-38T-16V2026-07-22
00841731140494ARTEMIS FUZEAV40-40T-16V2026-07-22
00841731140500ARTEMIS FUZEAV40-42T-16V2026-07-22
00841731140517ARTEMIS FUZEAV40-44T-16V2026-07-22
00841731140524ARTEMIS FUZEAV40-46T-16V2026-07-22
00841731140531ARTEMIS FUZEAV40-48T-16V2026-07-22
00841731140548ARTEMIS FUZEAV40-50T-16V2026-07-22
00841731140555ARTEMIS FUZEAV40-52T-16V2026-07-22
00841731140562ARTEMIS FUZEAV40-54T-16V2026-07-22
00841731140593ARTEMIS FUZEAV30-16T-11V2026-07-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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03700569604257NANEWCLIP TECHNICSHWC2024-11-15
03700569604271NANEWCLIP TECHNICSHWC2024-11-15
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03700569604318NANEWCLIP TECHNICSHWC2024-11-15
03700569604332NANEWCLIP TECHNICSHWC2024-11-15
03700569604356NANEWCLIP TECHNICSHWC2024-11-15
03700569604370NANEWCLIP TECHNICSHWC2024-11-15
03700569633936NANEWCLIP TECHNICSHWC2024-11-15
03700569633950NANEWCLIP TECHNICSHWC2024-11-15
03700569633974NANEWCLIP TECHNICSHWC2024-11-15
03700569633998NANEWCLIP TECHNICSHWC2024-11-15
03700569634018NANEWCLIP TECHNICSHWC2024-11-15
03700569634032NANEWCLIP TECHNICSHWC2024-11-15
03700569634056NANEWCLIP TECHNICSHWC2024-11-15
09353903015376NX Nail SystemFIELD ORTHOPAEDICS PTY LTDHWC2023-07-16
09353903015383NX Nail SystemFIELD ORTHOPAEDICS PTY LTDHWC2023-07-16
09353903015390NX Nail SystemFIELD ORTHOPAEDICS PTY LTDHWC2023-07-16
09353903015406NX Nail SystemFIELD ORTHOPAEDICS PTY LTDHWC2023-07-16
09353903015413NX Nail SystemFIELD ORTHOPAEDICS PTY LTDHWC2023-07-16
09353903015420NX Nail SystemFIELD ORTHOPAEDICS PTY LTDHWC2023-07-16
09353903015437NX Nail SystemFIELD ORTHOPAEDICS PTY LTDHWC2023-07-16
09353903015444NX Nail SystemFIELD ORTHOPAEDICS PTY LTDHWC2023-07-16
09353903015451NX Nail SystemFIELD ORTHOPAEDICS PTY LTDHWC2023-07-16
09353903015468NX Nail SystemFIELD ORTHOPAEDICS PTY LTDHWC2023-07-16
09353903015475NX Nail SystemFIELD ORTHOPAEDICS PTY LTDHWC2023-07-16
09353903015482NX Nail SystemFIELD ORTHOPAEDICS PTY LTDHWC2023-07-16
09353903015499NX Nail SystemFIELD ORTHOPAEDICS PTY LTDHWC2023-07-16