FDA.reportPublic FDA data

KineMatch® PFR System

Primary DI
00818720011318
Brand
KineMatch® PFR System
Company
Kinamed, Inc.
Model
Custom 266
Catalog number
Custom 266
Device description
CUSTOM PFR TRIAL IMPLANT RIGHT
Published
2023-06-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00818720011318PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00818720011318008187200113188187200113180818720011318

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical procedure kit, non-medicated, single-useA collection of various sterile orthopaedic surgical instruments, dressings, and other materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
184896645
Device count
1
Premarket exempt
true
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
00818720013305SuperCable® ISO-Elastic™ Cerclage System35-880-206035-880-20602022-10-03
00818720013312SuperCable® ISO-Elastic™ Cerclage System35-880-106035-880-10602022-10-03
00818720013329SuperCable® ISO-Elastic™ Cerclage System35-880-104035-880-10402022-10-03
00818720013336SuperCable® ISO-Elastic™ Cerclage System35-880-204035-880-20402022-10-03
00818720013299SuperCable® ISO-Elastic™ Cerclage System35-880-306035-880-30602022-09-27
00818720013381SuperCable® ISO-Elastic™ Cerclage System35-800-302235-800-30222026-05-29
00818720010007SuperCable® Grip and Plate System35-200-101035-200-10102015-10-28
00818720010014SuperCable® Grip and Plate System35-200-102035-200-10202015-10-28
00818720010021SuperCable® Grip and Plate System35-200-103035-200-10302015-10-28
00818720010038SuperCable® Grip and Plate System35-200-104035-200-10402015-10-27
00818720010069SuperCable® Grip and Plate System35-220-101035-220-10102015-10-28
00818720010076SuperCable® Grip and Plate System35-220-201035-220-20102015-10-28
00818720010083SuperCable® Grip and Plate System35-220-201235-220-20122015-10-28
00818720010090SuperCable® Grip and Plate System35-220-301035-220-30102015-10-28
00818720010106SuperCable® Grip and Plate System35-220-301235-220-30122015-10-28
00898142001906NeuroPro®14-1P1-127714-1P1-12772023-05-15
00898142001005NeuroPro®14-1P1-021114-1P1-02112015-11-09
00898142001029NeuroPro®14-1P1-081014-1P1-08102015-11-05
00898142001036NeuroPro®14-1P1-081214-1P1-08122015-11-05
00898142001050NeuroPro®14-1P1-041314-1P1-04132015-11-05

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Primary DI, Brand, Company table
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