FDA.report

ALPHALOK Plating System

Primary DI
00841731134066
Brand
ALPHALOK Plating System
Company
VILEX LLC
Model
TZ-DRILL-21
Catalog number
TZ-DRILL-21
Device description
ANKLE FX Drill, Hook Plate, Cannulated 2.1mm
Published
2024-02-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
HTWBit, Drill

Product Code Classifications

CodeDeviceSpecialtyClass
HTWBit, DrillOrthopedic1

Premarket Submissions

SubmissionSupplement
K230204000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K230204000ALPHALOK Plating SystemVilex, LLC2023-04-25HRS

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00841731134066PrimaryGS10

GMDN Terms

TermDefinition
Fluted surgical drill bit, single-useA shaft of metal with an obtuse, V-shaped cutting edge designed to be rotated to bore into bone to create a hole of the same dimension as the diameter of the shaft. This device, commonly called a "twist drill", has a cylindrical design with a double-edged cutting head that is formed from two spiralled flutes that extend the length of the insertion part of the drill. At the proximal end, it is mounted into a surgical power tool or a surgical hand drill/brace. This is a single-use device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
117502293
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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