FDA.reportPublic FDA data

Katalyst Bipolar Radial Head System

Primary DI
00885556834909
Brand
Katalyst Bipolar Radial Head System
Company
Smith & Nephew, Inc.
Model
600717
Catalog number
600717
Device description
HEX DRIVER. 2.5MM
Published
2023-02-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HXXSCREWDRIVER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXXScrewdriverOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00885556834909PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885556834909008855568349098855568349090885556834909

GMDN Terms#

Term, Definition table
TermDefinition
Joint prosthesis implantation kit, reusableA collection of surgical instruments used for cutting and forming bone to allow the implantation of a joint prosthesis. The instruments include various metallic and/or plastic reusable devices (e.g., retractors, rods, clamps, drills, pins, saws, guides, cutting blocks) that are specific to the joint of application (e.g., hip, knee, shoulder, ankle, or elbow); the implant(s) is not included. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)238-7538GUDID@SMITH-NEPHEW.COM

Regulatory Flags#

DUNS number
045483575
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00885556833933Salto Talaris Total Ankle ProsthesisMJU952TMJU952T2022-12-22
00885556833940Salto Talaris Total Ankle ProsthesisMJU953TMJU953T2022-12-22
00885556833957Salto Talaris Total Ankle ProsthesisMJV219TMJV219T2022-12-22
00885556833964Salto Talaris Total Ankle ProsthesisMJV220TMJV220T2022-12-22
00885556833971Salto Talaris Total Ankle ProsthesisMJV221TMJV221T2022-12-22
00885556833988Salto Talaris Total Ankle ProsthesisMJV229TMJV229T2022-12-22
00885556834237Silicone Toe SystemCGT-205TCGT-205T2022-12-22
00885556834251Silicone Toe SystemCGT-305TCGT-305T2022-12-22
00885556834299Silicone Toe SystemCGT-505TCGT-505T2022-12-22
00885556835029Ti6 Internal Fixation SystemDS1007DS10072022-12-22
00885556835203Surgical InstrumentsFS-1006FS-10062022-12-22
00885556836187Ti6 Internal Fixation SystemTH3018TH30182022-12-22
00885556837856Total Foot System 2220425022042502022-12-22
00885556838785Total Foot System 2282302728230272022-12-21
00885556841631XT Revision Ankle Replacement SystemMJU984TMJU984T2022-12-21
00885556841778XT Revision Ankle Replacement SystemMJV222TMJV222T2022-12-21
00885556841785XT Revision Ankle Replacement SystemMJV223TMJV223T2022-12-21
00885556854921Freedom Wrist Arthroplasty System3480473480472022-12-22
00885556856680Surgical InstrumentsEXT-200-00EXT-200-002022-12-22
00885556860168Titan Modular Shoulder System 2.5DRL-0923-047-001DRL-0923-047-0012022-12-22

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00824846003199Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-07-26
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10887587078557NASynthes GmbHHXX2026-07-24
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