FDA.reportPublic FDA data

Cannulated Drill and K-Wire Guide, 4.0mm

Primary DI
00810054093497
Brand
Cannulated Drill and K-Wire Guide, 4.0mm
Company
AVANTI ORTHOPAEDICS LLC
Model
CDG40
Device description
Cannulated Drill and K-Wire Guide, 4.0mm
Published
2022-12-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K222967000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222967000Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and 4.0mm Cannulated ScrewsAvanti Orthopaedics, Inc.2022-11-23HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810054093497PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810054093497008100540934978100540934970810054093497

GMDN Terms#

Term, Definition table
TermDefinition
Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterileA non-sterile assembly of implantable devices designed for the stabilization of fractured/surgically-cut bones of the limbs (long bones), their appendages (hands, feet), pelvis, craniomaxillofacial bones, and/or for limb-joint fusion. It typically consists of a set of bone fixation plates, screws, wires, and pins made of materials that cannot be chemically degraded or absorbed via natural body processes (e.g., implant grade metal, surgical steel, titanium alloy, or carbon fibre). It may also include instruments for the attachment of the implants such as screwdrivers or drills. This device is intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
043505370
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810054090014Volar Fixed Angle Plate, 3 Hole, LeftVFL032020-06-18
00810054090021Volar Fixed Angle Plate, 3 Hole, RightVFR032020-06-18
00810054090038Volar Fixed Angle Plate, 5 Hole, LeftVFL052020-06-18
00810054090045Volar Fixed Angle Plate, 5 Hole, RightVFR052020-06-18
00810054090052Volar Fixed Plate, Wide, 5 Hole, LeftVWL052020-06-18
00810054090069Volar Fixed Plate, Wide, 5 Hole, RightVWR052020-06-18
00810054090076Volar PEEK Plate, 3 Hole, LeftVPL032020-06-18
00810054090083Volar PEEK Plate, 3 Hole, RightVPR032020-06-18
00810054090090Volar PEEK Plate, 5 Hole, LeftVPL052020-06-18
00810054090106Volar PEEK Plate, 5 Hole, RightVPR052020-06-18
00810054090113Volar PEEK Plate, 7 Hole, LeftVPL072020-06-18
00810054090120Volar PEEK Plate, 7 Hole, RightVPR072020-06-18
00810054090137Volar PEEK Plate, 9 Hole, LeftVPL092020-06-18
00810054090144Volar PEEK Plate, 9 Hole, RightVPR092020-06-18
00810054090151Volar PEEK Plate, 11 Hole, LeftVPL112020-06-18
00810054090168Volar PEEK Plate, 11 Hole, RightVPR112020-06-18
00810054090175Ulnar Plate, 5 HoleULP052020-06-18
00810054090182Ulnar Plate, 7 HoleULP072020-06-18
00810054090199Straight Plate, 6 HoleSTP062020-06-18
00810054090205Straight Plate, 8 HoleSTP082020-06-18

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