FDA.reportPublic FDA data

CyclaPlex Drill Guide

Primary DI
07290017626192
Brand
CyclaPlex Drill Guide
Company
ALPHAMET LTD
Model
V7
Catalog number
DG-9201
Device description
The CyclaPlex Drill Guide is a “H arm” device intended to guide drill bits at the right points and required drilling angles in the 1st and 2nd metatarsal bones.
Published
2020-02-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTNWasher, Bolt Nut

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTNWasher, Bolt NutOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K183094000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K183094000CyclaPlex Correction SystemCycla Orthopedics, Ltd.2019-04-26HTN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290017626192PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290017626192072900176261927290017626192

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant aiming/guiding block attachment toolA manually-operated surgical instrument intended to be used to attach an orthopaedic implant aiming/guiding block to an implant (e.g., orthopaedic plate) to facilitate implantation. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
(260) 438-2198bcoburn@genorthopartners.com

Regulatory Flags#

DUNS number
600372473
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290017626017CyclaPlex ImplantV7IM-91012020-02-12
07290017626116CyclaPlex Correction System Instruments CaseV7IC-98012020-02-12
07290017626123CyclaPlex Correction System Instruments Case SetV7IC-98022020-02-12
07290017626161CyclaPlex Drill Bits 1.8-3.0 V7DB-92432020-02-12
07290017626826CyclaPlex ImplantV7IM-91012020-02-12
07290017626222CyclaPlex ScrewdriverV7SD-92212020-02-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850080543009PC Fix Locking Post TiChest Wall Innovations, Inc.HTN2026-06-01
00850080543016PC Fix Locking Cap TiChest Wall Innovations, Inc.HTN2026-06-01
00850080543023PC Fix Washer TiChest Wall Innovations, Inc.HTN2026-06-01
00850080543030PC Fix Extrathoracic Plate 70mm TiChest Wall Innovations, Inc.HTN2026-06-01
00850080543047PC Fix Extrathoracic Plate 95mm TiChest Wall Innovations, Inc.HTN2026-06-01
00850080543054PC Fix Intrathoracic Plate 70mm TiChest Wall Innovations, Inc.HTN2026-06-01
00850080543061PC Fix Intrathoracic Plate 95mm TiChest Wall Innovations, Inc.HTN2026-06-01
00850080543078PC Fix Thoracic Plate 70mm PEEKChest Wall Innovations, Inc.HTN2026-06-01
00850080543085PC Fix Thoracic Plate 95mm PEEKChest Wall Innovations, Inc.HTN2026-06-01
00850080543092PC Fix 3.2mm Drill Brad Point QCChest Wall Innovations, Inc.HTN2026-06-01
00850080543108PC Fix Graphic CaseChest Wall Innovations, Inc.HTN2026-06-01
00850080543115PC Fix Clamp/Drill Guide TopChest Wall Innovations, Inc.HTN2026-06-01
00850080543122PC Fix Clamp/Drill Guide BottomChest Wall Innovations, Inc.HTN2026-06-01
00850080543139PC Fix Compression ClampChest Wall Innovations, Inc.HTN2026-06-01
00850080543146PC Fix 3.2mm Drill Dental LatchChest Wall Innovations, Inc.HTN2026-06-01
00850080543184PC Fix Implant CaddyChest Wall Innovations, Inc.HTN2026-06-01
07901125602533Expert KnotlessGM DOS REIS INDUSTRIA E COMERCIO LTDAHTN2026-05-28
00888867251960Arthrex®ARTHREX, INC.HTN2017-11-28
00888867251939Arthrex®ARTHREX, INC.HTN2017-02-15
07613327075830ASNISStryker GmbHHTN2015-11-11
07613327076189ASNISStryker GmbHHTN2015-11-11
07613327076301ASNISStryker GmbHHTN2015-11-11
07613327076554ASNISStryker GmbHHTN2015-11-11
07613327076721ASNISStryker GmbHHTN2015-11-11
07613327076929ASNISStryker GmbHHTN2015-11-11
07613327077049ASNISStryker GmbHHTN2015-11-11
07613327073737VARIAXStryker GmbHHTN2015-09-30
07613327073768VARIAXStryker GmbHHTN2015-09-30
07613327073799VARIAXStryker GmbHHTN2015-09-30
07613327073812VARIAXStryker GmbHHTN2015-09-30