FDA.reportPublic FDA data

EVOS Cabling System

Primary DI
00191083003993
Brand
EVOS Cabling System
Company
Pioneer Surgical Technology, Inc.
Model
56-71175677
Catalog number
71175677
Device description
Cable Crimper
Published
2021-02-01
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
HXNAPPLIER, CERCLAGE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXNApplier, CerclageOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00191083003993PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191083003993001910830039931910830039930191083003993

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic wire crimperA hand-held manual surgical instrument designed like wire-closing forceps and used to bend wire or cerclage. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(386)418-8888labeling@rtix.com
+1(906)226-9909labeling@resolvesurg.com
+1(906)226-9909regulatory@exalta.com

Regulatory Flags#

DUNS number
793384496
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00846468049430nanOss ABGS90-100-0190-100-012015-12-14
00846468049447nanOss ABGS90-100-0290-100-022015-12-14
00846468049454nanOss ABGS90-100-0590-100-052015-12-14
00846468049461nanOss ABGS90-100-1090-100-102015-12-14
00846468049478nanOss ABGS90-100-2090-100-202015-12-14
00846468049515nanOss Loaded ABGS90-200-0590-200-052015-12-14
00846468049522nanOss Loaded ABGS90-200-1090-200-102015-12-14
00846468049546nanOss 3D ABGS90-300-2550490-300-255042015-12-14
00846468049553nanOss 3D ABGS90-300-2550890-300-255082015-12-14
00846468049560nanOss 3D ABGS90-300-25100490-300-2510042015-12-14
00846468049577nanOss 3D ABGS90-300-25100890-300-2510082015-12-14
00846468057411nanOss Loaded ABGS90-200-05K90-200-05K2015-12-14
00846468057428nanOss BA - Loaded90-200-10K90-200-10K2015-12-14
00846468087104nanOss® 3D Plus™90-400-2550490-400-255042018-09-19
00846468087111nanOss® 3D Plus™90-400-2550890-400-255082018-09-19
00846468087128nanOss® 3D Plus™90-400-25100890-400-2510082018-09-19
00846468087135nanOss® 3D Plus™90-400-25100490-400-2510042018-09-19
00840298703685CODA™ Anterior Cervical Plate System58-202230010S2022-30-010S2023-06-28
00840298703708CODA™ Anterior Cervical Plate System58-202230014S2022-30-014S2023-06-28
00840298701445CODA™ Anterior Cervical Plate System58-102201010S1022-01-010S2023-06-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03613720286783LIGAPASSMEDICREA INTERNATIONALHXN2021-05-25
00191083003931EVOS Cabling SystemPioneer Surgical Technology, Inc.HXN2021-02-01
00191083003948EVOS Cabling SystemPioneer Surgical Technology, Inc.HXN2021-02-01
00191083003986EVOS Cabling SystemPioneer Surgical Technology, Inc.HXN2021-02-01
04038653174676AESCULAPAesculap AGHXN2020-04-22
04038653174683AESCULAPAesculap AGHXN2020-04-22
04038653174713AESCULAPAesculap AGHXN2020-04-22
00889024039575Cable-Ready®Zimmer, Inc.HXN2016-07-02
00880304002708BMP CABLE SYSTEMBiomet Orthopedics, LLCHXN2015-10-24
00880304360556BMP CABLE SYSTEMBiomet Orthopedics, LLCHXN2015-10-24