OIC Pedicle Screw System

GUDID M69632400P1

CALIBRATED GUIDE PIN 3.2MM X 400MM

ORTHOPAEDIC IMPLANT COMPANY, THE

Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable
Primary Device IDM69632400P1
NIH Device Record Keyd11dbf1b-7c66-48e5-b17d-0a9d541154ac
Commercial Distribution Discontinuation2024-01-01
Commercial Distribution StatusNot in Commercial Distribution
Brand NameOIC Pedicle Screw System
Version Model Number32-400P
Company DUNS070061160
Company NameORTHOPAEDIC IMPLANT COMPANY, THE
Device Count5
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone775 636 8281
EmailInfo@OrthoImplantCompany.com
Phone775 636 8281
EmailInfo@OrthoImplantCompany.com
Phone775 636 8281
EmailInfo@OrthoImplantCompany.com
Phone775 636 8281
EmailInfo@OrthoImplantCompany.com
Phone775 636 8281
EmailInfo@OrthoImplantCompany.com
Phone775 636 8281
EmailInfo@OrthoImplantCompany.com
Phone775 636 8281
EmailInfo@OrthoImplantCompany.com
Phone775 636 8281
EmailInfo@OrthoImplantCompany.com
Phone775 636 8281
EmailInfo@OrthoImplantCompany.com
Phone775 636 8281
EmailInfo@OrthoImplantCompany.com
Phone775 636 8281
EmailInfo@OrthoImplantCompany.com
Phone775 636 8281
EmailInfo@OrthoImplantCompany.com
Phone775 636 8281
EmailInfo@OrthoImplantCompany.com
Phone775 636 8281
EmailInfo@OrthoImplantCompany.com
Phone775 636 8281
EmailInfo@OrthoImplantCompany.com
Phone775 636 8281
EmailInfo@OrthoImplantCompany.com
Phone775 636 8281
EmailInfo@OrthoImplantCompany.com
Phone775 636 8281
EmailInfo@OrthoImplantCompany.com
Phone775 636 8281
EmailInfo@OrthoImplantCompany.com
Phone775 636 8281
EmailInfo@OrthoImplantCompany.com
Phone775 636 8281
EmailInfo@OrthoImplantCompany.com
Phone775 636 8281
EmailInfo@OrthoImplantCompany.com
Phone775 636 8281
EmailInfo@OrthoImplantCompany.com
Phone775 636 8281
EmailInfo@OrthoImplantCompany.com
Phone775 636 8281
EmailInfo@OrthoImplantCompany.com
Phone775 636 8281
EmailInfo@OrthoImplantCompany.com
Phone775 636 8281
EmailInfo@OrthoImplantCompany.com
Phone775 636 8281
EmailInfo@OrthoImplantCompany.com
Phone775 636 8281
EmailInfo@OrthoImplantCompany.com
Phone775 636 8281
EmailInfo@OrthoImplantCompany.com
Phone775 636 8281
EmailInfo@OrthoImplantCompany.com
Phone775 636 8281
EmailInfo@OrthoImplantCompany.com
Phone775 636 8281
EmailInfo@OrthoImplantCompany.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM69632400P0 [Unit of Use]
HIBCCM69632400P1 [Primary]

FDA Product Code

MNIOrthosis, Spinal Pedicle Fixation

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M69632400P1]

Moist Heat or Steam Sterilization

[M69632400P1]

Moist Heat or Steam Sterilization

[M69632400P1]

Moist Heat or Steam Sterilization

[M69632400P1]

Moist Heat or Steam Sterilization

[M69632400P1]

Moist Heat or Steam Sterilization

[M69632400P1]

Moist Heat or Steam Sterilization

[M69632400P1]

Moist Heat or Steam Sterilization

[M69632400P1]

Moist Heat or Steam Sterilization

[M69632400P1]

Moist Heat or Steam Sterilization

[M69632400P1]

Moist Heat or Steam Sterilization

[M69632400P1]

Moist Heat or Steam Sterilization

[M69632400P1]

Moist Heat or Steam Sterilization

[M69632400P1]

Moist Heat or Steam Sterilization

[M69632400P1]

Moist Heat or Steam Sterilization

[M69632400P1]

Moist Heat or Steam Sterilization

[M69632400P1]

Moist Heat or Steam Sterilization

[M69632400P1]

Moist Heat or Steam Sterilization

[M69632400P1]

Moist Heat or Steam Sterilization

[M69632400P1]

Moist Heat or Steam Sterilization

[M69632400P1]

Moist Heat or Steam Sterilization

[M69632400P1]

Moist Heat or Steam Sterilization

[M69632400P1]

Moist Heat or Steam Sterilization

[M69632400P1]

Moist Heat or Steam Sterilization

[M69632400P1]

Moist Heat or Steam Sterilization

[M69632400P1]

Moist Heat or Steam Sterilization

[M69632400P1]

Moist Heat or Steam Sterilization

[M69632400P1]

Moist Heat or Steam Sterilization

[M69632400P1]

Moist Heat or Steam Sterilization

[M69632400P1]

Moist Heat or Steam Sterilization

[M69632400P1]

Moist Heat or Steam Sterilization

[M69632400P1]

Moist Heat or Steam Sterilization

[M69632400P1]

Moist Heat or Steam Sterilization

[M69632400P1]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2024-06-04
Device Publish Date2017-02-01

On-Brand Devices [OIC Pedicle Screw System]

M69623020410STERILIZATION CASE PEDICLE SCREW CASE 2
M69623010410STERILIZATION CASE PEDICLE SCREW CASE
M69633710200BONE AWL
M6962261020R0IN SITU RIGHT
M6962261010L0IN SITU LEFT
M69622310200ROD BENDER
M69622111200DISTRACTOR
M69622011200COMPRESSOR
M696SP2001607.5MM BONE TAP
M696SP2001506.5MM BONE TAP
M696SP2001405.5MM BONE TAP
M696SR55800STRAIGHT ROD, 80MM
M696SR55700STRAIGHT ROD, 70MM
M696SR55500STRAIGHT ROD, 50MM
M696SR55400STRAIGHT ROD, 40MM
M696SR552000STRAIGHT ROD, 200MM
M696SR551800STRAIGHT ROD, 180MM
M696SR551500STRAIGHT ROD, 150MM
M696SR551200STRAIGHT ROD, 120MM
M696SR551100STRAIGHT ROD, 110MM
M696SR551000STRAIGHT ROD, 100MM
M696SP5555550PEDICLE SCREW, POLYAXIAL, 5.5MM X 55MM
M696SP200210SHEATH, IMPLANT DRIVER
M696SP200120SET SCREW GUIDE
M696SP200070CONNECTOR HEX DRIVER
M696SP200060CONNECTOR SCREW DRIVER
M696SP200050HEAD TILTING WRENCH
M696SP200040IMPLANT DRIVER
M696SP200030SET SCREW DRIVER
M696SP200020ROD PERSUADER
M696SP200010SET SCREW INSTALLATION DRIVER
M696SP200000ANTI TORQUE WRENCH
M696PS5575550PEDICLE SCREW, POLYAXIAL, 7.5MM X 55MM
M696PS5575500PEDICLE SCREW, POLYAXIAL, 7.5MM X 50MM
M696PS5575450PEDICLE SCREW, POLYAXIAL, 7.5MM X 45MM
M696PS5575400PEDICLE SCREW, POLYAXIAL, 7.5MM X 40MM
M696PS5575350PEDICLE SCREW, POLYAXIAL, 7.5MM X 35MM
M696PS5575300PEDICLE SCREW, POLYAXIAL, 7.5MM X 30MM
M696PS5565550PEDICLE SCREW, POLYAXIAL, 6.5MM X 55MM
M696PS5565500PEDICLE SCREW, POLYAXIAL, 6.5MM X 50MM
M696PS5565450PEDICLE SCREW, POLYAXIAL, 6.5MM X 45MM
M696PS5565400PEDICLE SCREW, POLYAXIAL, 6.5MM X 40MM
M696PS5565350PEDICLE SCREW, POLYAXIAL, 6.5MM X 35MM
M696PS5565300PEDICLE SCREW, POLYAXIAL, 6.5MM X 30MM
M696PS5555550PEDICLE SCREW, POLYAXIAL, 5.5MM X 55MM
M696PS5555500PEDICLE SCREW, POLYAXIAL, 5.5MM X 50MM
M696PS5555450PEDICLE SCREW, POLYAXIAL, 5.5MM X 45MM
M696PS5555400PEDICLE SCREW, POLYAXIAL, 5.5MM X 40MM
M696PS5555350PEDICLE SCREW, POLYAXIAL, 5.5MM X 35MM
M696PS5555300PEDICLE SCREW, POLYAXIAL, 5.5MM X 30MM
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