FDA.reportPublic FDA data

OrthoCircle Spine Pedicle Screw System

Primary DI
00810005111614
Brand
OrthoCircle Spine Pedicle Screw System
Company
OrthoCircle Spine
Model
101.137
Device description
50mm Rod Trial
Published
2020-04-13
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
NKBThoracolumbosacral Pedicle Screw System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810005111614PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810005111614008100051116148100051116140810005111614

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant/trial-implant/sizer holder, reusableA hand-held manual surgical instrument designed to connect to and hold an orthopaedic implant (e.g., bone screw, bone graft), trial implant, or sizer (e.g., glenoid defect sizer) to facilitate guidance, gauging/sizing, and/or monitoring of the held device during an orthopaedic surgical intervention. The instrument is typically made of high-grade stainless steel or synthetic polymer materials and is typically constructed in the form of a long shaft with a handle at the proximal end and a device holding/fixation mechanism at the distal end (e.g., a threaded portion or a clamp mechanism). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
040985864
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810005110266OrthoCircle Spine Pedicle Screw System101.1272020-04-13
00810005110273OrthoCircle Spine Pedicle Screw System101.1282020-04-13
00810005110150OrthoCircle Spine Pedicle Screw System101.1162020-04-10
00810005111249OrthoCircle Spine Pedicle Screw SystemSSC1.0112020-03-29
00810005110778OrthoCircle Spine Pedicle Screw SystemPR45055.S112020-07-21
00810005110792OrthoCircle Spine Pedicle Screw SystemPR45050.S112020-07-21
00810005110808OrthoCircle Spine Pedicle Screw SystemPR45045.S112020-07-21
00810005110815OrthoCircle Spine Pedicle Screw SystemPR45060.S112020-07-21
00810005110822OrthoCircle Spine Pedicle Screw SystemPR55020.S112020-07-21
00810005110730OrthoCircle Spine Pedicel Screw SystemPR45020.S112020-07-09
00810005110747OrthoCircle Spine Pedicle Screw SystemPR45025.S112020-07-09
00810005110754OrthoCircle Spine Pedicle Screw SystemPR45030.S112020-07-09
00810005110761OrthoCircle Spine Pedicle Screw SystemPR45035.S112020-07-09
00810005110785OrthoCircle Spine Pedicle Screw SystemPR45040.S112020-07-09
00810005110471OrthoCircle Spine Pedicel Screw SystemPNR55020.S112020-05-14
00810005110488OrthoCircle Spine Pedicle Screw SystemPNR55025.S112020-05-14
00810005110532OrthoCircle Spine Pedicle Screw SystemPNR55050.S112020-05-14
00810005110549OrthoCircle Spine Pedicle Screw SystemPNR55055.S112020-05-14
00810005110556OrthoCircle Spine Pedicle Screw SystemPNR55060.S112020-05-14
00810005110570OrthoCircle Spine Pedicle Screw SystemPNR65020.S112020-05-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840493423166RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423173RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423180RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423197RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423203RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423210RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423227RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423234RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423241RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423258RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423265RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423272RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423289RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423296RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423302RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423319RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423326RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423333RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423340RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423357RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423364RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423371RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423388RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423395RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423401RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423418RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423425RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423432RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423449RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423456RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08