FDA.reportPublic FDA data

CyclaPlex Drill Bits 1.8-3.0

Primary DI
07290017626161
Brand
CyclaPlex Drill Bits 1.8-3.0
Company
ALPHAMET LTD
Model
V7
Catalog number
DB-9243
Device description
The 1.8 and 3.0 mm quick coupling drill bits are intended to be used for implantation of CyclaPlex Implant.
Published
2020-02-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
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
07290017626178PackageGS15In Commercial Distribution
07290017626864PackageGS120In Commercial Distribution
07290017626161PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290017626178072900176261787290017626178
07290017626864072900176268647290017626864
07290017626161072900176261617290017626161

GMDN Terms#

Term, Definition table
TermDefinition
Fluted surgical drill bit, single-use, non-sterileA non-sterile 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, its shaft is mounted into a surgical power tool or a surgical hand drill/brace. This is a single-use device intended to be sterilized prior to use.

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
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
07290017626826CyclaPlex ImplantV7IM-91012020-02-12
07290017626192CyclaPlex Drill GuideV7DG-92012020-02-12
07290017626222CyclaPlex ScrewdriverV7SD-92212020-02-12

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