CFCPX

Primary DI
00857915007019
Brand
CFCPX
Company
A.M. SURGICAL, INC.
Model
8800-81
Device description
Carbon Fiber CPX
Published
2018-09-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal CompositeOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K042458000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K042458000A.M. SURGICAL CPF DISTAL RADIAL EXTERNAL CROSS PIN FIXATION SYSTEMA.M. Surgical, Inc.2004-10-07LXT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857915007392PackageGS11In Commercial Distribution
00857915007019PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857915007392008579150073928579150073920857915007392
00857915007019008579150070198579150070190857915007019

GMDN Terms#

Term, Definition table
TermDefinition
External orthopaedic fixation system, single-use, sterileAn assembly of sterile devices designed to stabilize fractured bones of the lower limbs to promote treatment and healing. It typically consists of an external plastic and/or metallic fixator (a framework) and other external and/or implantable components such as clamps, rods, rings, pins, bolts, and nuts, as well as some reusable instrumentation (e.g., wrenches, depth gauge, tensioner). It is used mainly to help the healing of long bones such as the femur and tibia, as well as fractures of the foot and ankle, joint fusions, and limb lengthening. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
6319799777service@amsurgical.com

Regulatory Flags#

DUNS number
160020087
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00857915007026Scope Adapter1200-012026-06-01
00857915007712Obturator9600-012026-06-01
00857915007729Cannula9600-022026-06-01
00857915007736Rasp9600-032026-06-01
00857915007132Stratos55002019-07-17
10857915007047RETRA5500-RN/A2026-05-20
00857915007040RETRA5500-SR2026-05-20
00857915007651Elevator9600-062026-05-20
00857915007668Dilator-Small9600-072026-05-20
00857915007675Dilator-Medium9600-082026-05-20
00857915007682Dilator-Large9600-092026-05-20
00857915007699Locking Attachment9600-042026-05-20
00857915007286Secure IM Nail8960-652019-11-14
00857915007293Secure IM Nail8960-702019-11-14
00857915007309Secure IM Nail8912-302019-11-14
00857915007316Secure IM Nail8912-352019-11-14
00857915007323Secure IM Nail8912-402019-11-14
00857915007330Secure IM Nail8912-452019-11-14
00857915007347Secure IM Nail8912-502019-11-14
00857915007354Secure IM Nail8912-552019-11-14

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08800089416592INLET System Bone ScrewJeil Medical CorporationLXT2021-11-18
08800089416608INLET System Bone ScrewJeil Medical CorporationLXT2021-11-18
08800089416615INLET System Bone ScrewJeil Medical CorporationLXT2021-11-18
08800089416622INLET System Bone ScrewJeil Medical CorporationLXT2021-11-18
08800089416639INLET System Bone ScrewJeil Medical CorporationLXT2021-11-18
08800089416646INLET System Bone ScrewJeil Medical CorporationLXT2021-11-18
08800089416653INLET System Bone ScrewJeil Medical CorporationLXT2021-11-18
08800089416660INLET System Bone ScrewJeil Medical CorporationLXT2021-11-18
08800089416677INLET System Bone ScrewJeil Medical CorporationLXT2021-11-18
08800089416684INLET System Bone ScrewJeil Medical CorporationLXT2021-11-18
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