FDA.reportPublic FDA data

OrthoCircle Spine Pedicle Screw System

Primary DI
00810005110150
Brand
OrthoCircle Spine Pedicle Screw System
Company
OrthoCircle Spine
Model
101.116
Device description
French Bender
Published
2020-04-10
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
00810005110150PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810005110150008100051101508100051101500810005110150

GMDN Terms#

Term, Definition table
TermDefinition
Manual orthopaedic bender, reusableA manually-operated surgical instrument designed to bend orthopaedic devices, typically those for implantation (e.g., orthopaedic rods, bone fixation plates), to an appropriate anatomical shape. The bending process is typically performed within the operating room (OR), inside or outside of the operative sterile field. The device may be hand held or table mounted. 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
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
00810005110594OrthoCircle Spine Pedicel Screw SystemPNR65030.S112020-05-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840493426426RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-18
00840493426433RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-18
00840493426440RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-18
00840493426457RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-18
00840493426464RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-18
00840493426471RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-18
00840493426488RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-18
00840493426495RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-18
00840493426501RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-18
00840493426518RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-18
00840493426525RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-18
00840493426532RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-18
00840493426549RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-18
00840493426556RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-18
00840493426563RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-18
00840493426570RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-18
00840493426587RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-18
00840493426594RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-18
00840493426600RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-18
00840493426617RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-18
00840493426624RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-18
00840493426631RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-18
M719IST80030C0TiLockGenesys Orthopedics Systems LLCNKB2026-08-18
M719IST80035C0TiLockGenesys Orthopedics Systems LLCNKB2026-08-18
M719IST80040C0TiLockGenesys Orthopedics Systems LLCNKB2026-08-18
M719IST80045C0TiLockGenesys Orthopedics Systems LLCNKB2026-08-18
M719IST80050C0TiLockGenesys Orthopedics Systems LLCNKB2026-08-18
M719IST80055C0TiLockGenesys Orthopedics Systems LLCNKB2026-08-18
M719IST80060C0TiLockGenesys Orthopedics Systems LLCNKB2026-08-18
M719IST80065C0TiLockGenesys Orthopedics Systems LLCNKB2026-08-18