FDA.reportPublic FDA data

CyclaPlex Correction System Instruments Case Set

Primary DI
07290017626123
Brand
CyclaPlex Correction System Instruments Case Set
Company
ALPHAMET LTD
Model
V7
Catalog number
IC-9802
Device description
The CyclaPlex Correction System Instruments Case Set is comprised of the following instruments delivered together.Instruments Case 07290017626116Drill Guide 07290017626192Screwdriver 07290017626222
Published
2020-02-12
Public version status
Update
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
07290017626123PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290017626123072900176261237290017626123

GMDN Terms#

Term, Definition table
TermDefinition
Sterilization/disinfection containerA receptacle designed to hold wrapped and/or unwrapped medical devices in a chemical washer/disinfector and/or sterilizer during the washing/disinfection and/or sterilization cycle(s). It may be designed as a tray to allow full or partial immersion of the devices in a liquid disinfectant, or as an enclosed box to prevent contamination once the sterilization process is finished. The container may also be used for transport and storage of the processed devices, and may have features such as an expiry date label, breathing filter, built-in slots for microsurgical instruments, and stacking capabilities. 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
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
07290017626161CyclaPlex Drill Bits 1.8-3.0 V7DB-92432020-02-12
07290017626826CyclaPlex ImplantV7IM-91012020-02-12
07290017626192CyclaPlex Drill GuideV7DG-92012020-02-12
07290017626222CyclaPlex ScrewdriverV7SD-92212020-02-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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07901125602533Expert KnotlessGM DOS REIS INDUSTRIA E COMERCIO LTDAHTN2026-05-28
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