FDA.reportPublic FDA data

Vilex Fibula Tool

Primary DI
00841731122032
Brand
Vilex Fibula Tool
Company
VILEX LLC
Model
ZF-T10
Catalog number
ZF-T10
Device description
Driver, Fibula T10 Long
Published
2018-08-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HSBRod, Fixation, Intramedullary And Accessories
HXXScrewdriver

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSBRod, Fixation, Intramedullary And AccessoriesOrthopedic2
HXXScrewdriverOrthopedic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K151456000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151456000Small Bone Nail ImplantVilex IN Tennessee, Inc.2015-10-29HSB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841731122032PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841731122032008417311220328417311220320841731122032

GMDN Terms#

Term, Definition table
TermDefinition
Surgical screwdriver, reusableA non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. This is a reusable device.

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
00841731135483TITANEX H4102026-05-15
00841731135568TITANEX K150-16SC2026-05-15
00841731137319TITANEX ART-KW2-1012026-05-15
00841731137906TITANEXK150-09S2026-05-15
00841731137913TITANEX TH-DRILL-202026-05-15
00841731137920TITANEX TH-DRILL-252026-05-15
00841731137937TITANEXTH-DEPTHTH-DEPTH2026-05-15
00841731137951TITANEX TH-DT72026-05-15
00841731137968TITANEX TH-DT82026-05-15
00841731138095TITANEX ART-KW2-1902026-05-15
00841731138101TITANEX ART-KWS-222026-05-15
00841731138118TITANEX ART-DTH-652026-05-15
00841731138125TITANEX ART-STP-492026-05-15
00841731138132TITANEX ART-DBC-492026-05-15
00841731138149TITANEX ART-RT-T252026-05-15
00841731138156TITANEX ART-VZO-152026-05-15
00841731140777TITANEX AZ-D130-262026-05-15
00841731140784TITANEX AZ-DT10-CR2026-05-15
00841731141910TITANEX AZ-D150-332026-05-15
00841731141927TITANEX AZ-DT15-CR2026-05-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B058AHN08165L1Atlas™ Humeral Nail SystemOrthopedic Designs North America, Inc.HSB2026-05-29
B058AHN08165R1Atlas™ Humeral Nail SystemOrthopedic Designs North America, Inc.HSB2026-05-29
07640221373076PERLA ® TLSpineArt SAHXX2026-05-07
07640332475294PERLA ®SpineArt SAHXX2025-11-10
07640332475300PERLA ®SpineArt SAHXX2025-11-10
07640332475317PERLA ®SpineArt SAHXX2025-11-10
00841732142312GENERIC Surgical InstrumentsCTL Medical CorporationHXX2025-03-31
00841732142428GENERIC Surgical InstrumentsCTL Medical CorporationHXX2025-03-31
00841732142435GENERIC Surgical InstrumentsCTL Medical CorporationHXX2025-03-31
00841732142442GENERIC Surgical InstrumentsCTL Medical CorporationHXX2025-03-31
00841732142459GENERIC Surgical InstrumentsCTL Medical CorporationHXX2025-03-31
00841732142466GENERIC Surgical InstrumentsCTL Medical CorporationHXX2025-03-31
00841732142473GENERIC Surgical InstrumentsCTL Medical CorporationHXX2025-03-31
00841732143074GENERIC Surgical InstrumentsCTL Medical CorporationHXX2025-03-31
00841732145078GENERIC Surgical InstrumentsCTL Medical CorporationHXX2025-03-31
00841732160347GENERIC Surgical InstrumentsCTL Medical CorporationHXX2025-03-31
00841732142190GENERIC Surgical InstrumentsCTL Medical CorporationHXX2025-03-28
00841732166721GENERIC Surgical InstrumentsCTL Medical CorporationHXX2024-12-04
00841732166738GENERIC Surgical InstrumentsCTL Medical CorporationHXX2024-12-04
00841732162792VALEOCTL Medical CorporationHXX2024-10-02
00810118210198Torque WrenchOsteocentric Technologies, Inc.HXX2023-10-31
00810118210259.050 Driver, ShortOsteocentric Technologies, Inc.HXX2023-10-31
00810118210266.050 Driver, LongOsteocentric Technologies, Inc.HXX2023-10-31
00810118210273.050 Driver, LatchOsteocentric Technologies, Inc.HXX2023-10-31
00810118210280Thumb KnobOsteocentric Technologies, Inc.HXX2023-10-31
00810118210327Latch Driver, 300 SeriesOsteocentric Technologies, Inc.HXX2023-10-31
00810118210334Square Driver, 300 SeriesOsteocentric Technologies, Inc.HXX2023-10-31
00810118210341Latch Driver, 400 SeriesOsteocentric Technologies, Inc.HXX2023-10-31
00810118210358Square Driver, 400 SeriesOsteocentric Technologies, Inc.HXX2023-10-31
00810118210365Ratchet AdapterOsteocentric Technologies, Inc.HXX2023-10-31