FDA.reportPublic FDA data

Vilex Implant Accessory

Primary DI
00841731114846
Brand
Vilex Implant Accessory
Company
VILEX LLC
Model
635-65T
Device description
Washer, 6.5mm Ti Screws .468x.275x.040
Published
2017-02-02
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
K991151000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K991151000VILEX CANNULATED BONE SCREW, DUVAL CANNULATED BONE SCREW, ORTHEX CANNULATED BONE SCREWVilex, Inc.1999-04-26HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841731114846PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841731114846008417311148468417311148460841731114846

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone washer, non-sterileA non-sterile flat thin ring or plate designed to be used with a nut and bolt/screw to improve tightness in an orthopaedic fixation assembly. It may be made of metal, polymer, or reinforced polymer. This is a single-use 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
00889929072745NEXXT MATRIXX® SI SystemNEXXT SPINE, LLCHWC2026-07-17
07613327646825NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327646832NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327646849NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327646856NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327646863NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327646870NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327646887NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327646894NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327646900NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327646917NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327646931NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327646948NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327646955NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327646962NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327646979NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327646986NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327646993NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327647006NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327647013NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327647020NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327647037NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327647044NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327647051NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
37613327647069NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
37613327647076NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
37613327647090NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
37613327647106NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
37613327647113NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
37613327647120NAStryker Leibinger GmbH & Co. KGHWC2026-07-17