Orthopediatrics Instrumentation 01-1800-1060

GUDID 00841132173121

6.0mm Tap, Navigation

ORTHOPEDIATRICS CORP.

Orthopaedic surgical procedure kit, non-medicated, reusable
Primary Device ID00841132173121
NIH Device Record Key517484d5-0b64-4cdd-b3a7-ab8bf4126f36
Commercial Distribution StatusIn Commercial Distribution
Brand NameOrthopediatrics Instrumentation
Version Model Number01-1800-1060
Catalog Number01-1800-1060
Company DUNS796416191
Company NameORTHOPEDIATRICS CORP.
Device Count1
DM Exempttrue
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(574)268-6379
Emailbsmith@orthopediatric.com
Phone+1(574)268-6379
Emailyli@orthopediatrics.com
Phone+1(574)268-6379
Emailyli@orthopediatrics.com
Phone+1(574)268-6379
Emailyli@orthopediatrics.com
Phone+1(574)268-6379
Emailyli@orthopediatrics.com
Phone+1(574)268-6379
Emailyli@orthopediatrics.com
Phone+1(574)268-6379
Emailyli@orthopediatrics.com
Phone+1(574)268-6379
Emailyli@orthopediatrics.com
Phone+1(574)268-6379
Emailyli@orthopediatrics.com
Phone+1(574)268-6379
Emailyli@orthopediatrics.com
Phone+1(574)268-6379
Emailyli@orthopediatrics.com
Phone+1(574)268-6379
Emailyli@orthopediatrics.com
Phone+1(574)268-6379
Emailyli@orthopediatrics.com
Phone+1(574)268-6379
Emailyli@orthopediatrics.com
Phone+1(574)268-6379
Emailyli@orthopediatrics.com
Phone+1(574)268-6379
Emailyli@orthopediatrics.com
Phone+1(574)268-6379
Emailyli@orthopediatrics.com
Phone+1(574)268-6379
Emailyli@orthopediatrics.com
Phone+1(574)268-6379
Emailyli@orthopediatrics.com
Phone+1(574)268-6379
Emailyli@orthopediatrics.com
Phone+1(574)268-6379
Emailyli@orthopediatrics.com
Phone+1(574)268-6379
Emailyli@orthopediatrics.com
Phone+1(574)268-6379
Emailyli@orthopediatrics.com
Phone+1(574)268-6379
Emailyli@orthopediatrics.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100841132173121 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GFGBIT, SURGICAL
HRSPlate, fixation, bone
OLOOrthopedic stereotaxic instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00841132173121]

Moist Heat or Steam Sterilization

[00841132173121]

Moist Heat or Steam Sterilization

[00841132173121]

Moist Heat or Steam Sterilization

[00841132173121]

Moist Heat or Steam Sterilization

[00841132173121]

Moist Heat or Steam Sterilization

[00841132173121]

Moist Heat or Steam Sterilization

[00841132173121]

Moist Heat or Steam Sterilization

[00841132173121]

Moist Heat or Steam Sterilization

[00841132173121]

Moist Heat or Steam Sterilization

[00841132173121]

Moist Heat or Steam Sterilization

[00841132173121]

Moist Heat or Steam Sterilization

[00841132173121]

Moist Heat or Steam Sterilization

[00841132173121]

Moist Heat or Steam Sterilization

[00841132173121]

Moist Heat or Steam Sterilization

[00841132173121]

Moist Heat or Steam Sterilization

[00841132173121]

Moist Heat or Steam Sterilization

[00841132173121]

Moist Heat or Steam Sterilization

[00841132173121]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-03-17
Device Publish Date2020-03-05

On-Brand Devices [Orthopediatrics Instrumentation]

00841132177211Wire Caddy
008411321744631.6mm wire collet
008411321744562.0mm wire collet
00841132174449Articulating distractor
00841132174418Tendon Passer, 2.4mm x 400mm
00841132174401Tendon Passer, 2.4mm x 300mm
008411321743711.6mm Mini Tack, 40mm, Smooth
008411321743641.6mm Mini Tack, 35mm, Smooth
008411321743571.6mm Mini Tack, 40mm, Threaded
008411321743401.6mm Mini Tack, 35mm, Threaded
008411321743331.6mm Mini Tack, 30mm, Smooth
008411321731381.6mm Mini Tack, 40mm, Threaded
008411321775016.5mm Fully Threaded Cannulated Screw Caddy
008411321774957.3mm Fully Threaded Cannulated Screw Caddy
008411321774886.5/7.3mm Cannulated Screw Instrument Tray Long
008411321774646.5mm Partially Threaded Cannulated Screw Caddy
008411321774577.3mm Partially Threaded Cannulated Screw Caddy
008411321774406.5/7.3mm Cannulated Screw Instrument Tray Short
00841132177433Long 6.5/7.3 SCFE Base Tray
00841132177259LARGE FRENCH BENDERS
008411321772426.5mm Fully Threaded Cannulated Screw Caddy
008411321772357.3mm Partially Threaded Cannulated Screw Caddy
008411321772287.3mm Fully Threaded Cannulated Screw Caddy
00841132177204RETAINING SLEEVE DRIVER, LONG
00841132177198RETAINING SLEEVE DRIVER, SHORT
00841132177174RETAINING SLEEVE DRIVER, LONG
008411321768633.2mm Cleaning Stylet, Long
008411321766276.5mm/7.3mm Cannulated Screw retaining Sleeve, Short
008411321766032.7MM/3.5MM WRIST FUSION PLATE BENDING TEMPLATE, 99MM
008411321765734.5MM LOCKING SCREW GUIDE - OUTER TUBE
008411321765664.5MM LOCKING SCREW GUIDE - INNER TUBE
008411321765593.5MM LOCKING SCREW GUIDE - OUTER TUBE
008411321765423.5MM LOCKING SCREW GUIDE - INNER TUBE
008411321756443.2mm Cleaning Stylet, Short
008411321756373.2mm SCFE Wire Guide Inserter, Short
00841132175620Cannulated Countersink 6.5/7.3mm screw, Long
00841132175613Cannulated Countersink 6.5/7.3mm screw, Short
00841132175606Direct Measuring Device, 3.2 x 300mm Wire
00841132175590Direct Measuring Device - 3.2 x 375mm Wire
00841132175583Zimmer Inline Ratcheting Handle, Cannulated
008411321743881.25mm Guide Wire Caddy
008411321742415.0mm Hex Driver, Retaining, Cannulated, Long
008411321742342.7mm Cannulated Drill, Long
008411321742275.6/3.2 Double Drill Guide
008411321742104.0/2.0 Double Drill Guide
008411321742033.2/1.6 Double Drill Guide
008411321741975.0mm Hex Driver, Retaining, Cannulated, Short
008411321741802.7mm Cannulated Drill, Short
008411321741739.25mm Trephine
008411321741664.5mm Locking Compression Femur Case Inner Tray
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.