PRECICE Trauma Nail System CDT11.5-30T240

GUDID 00812258027322

Orthopedic trauma intramedullary rod, antegrade tibia 10° bend, 11.5 mm diameter, 240 mm length

NUVASIVE SPECIALIZED ORTHOPEDICS, INC.

Tibia nail, sterile
Primary Device ID00812258027322
NIH Device Record Keyd0053ae6-d540-4ef7-8903-b3452552da2a
Commercial Distribution StatusIn Commercial Distribution
Brand NamePRECICE Trauma Nail System
Version Model NumberCDT11.5-30T240
Catalog NumberCDT11.5-30T240
Company DUNS837845234
Company NameNUVASIVE SPECIALIZED ORTHOPEDICS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone855-435-5477
Emailcsdepartment@nuvasive.com
Phone855-435-5477
Emailcsdepartment@nuvasive.com
Phone855-435-5477
Emailcsdepartment@nuvasive.com
Phone855-435-5477
Emailcsdepartment@nuvasive.com
Phone855-435-5477
Emailcsdepartment@nuvasive.com
Phone855-435-5477
Emailcsdepartment@nuvasive.com
Phone855-435-5477
Emailcsdepartment@nuvasive.com
Phone855-435-5477
Emailcsdepartment@nuvasive.com
Phone855-435-5477
Emailcsdepartment@nuvasive.com
Phone855-435-5477
Emailcsdepartment@nuvasive.com

Device Dimensions

Outer Diameter11.5 Millimeter
Outer Diameter11.5 Millimeter
Outer Diameter11.5 Millimeter
Outer Diameter11.5 Millimeter
Outer Diameter11.5 Millimeter
Outer Diameter11.5 Millimeter
Outer Diameter11.5 Millimeter
Outer Diameter11.5 Millimeter
Outer Diameter11.5 Millimeter
Outer Diameter11.5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100812258027322 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HSBRod, Fixation, Intramedullary And Accessories

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-09-19

Devices Manufactured by NUVASIVE SPECIALIZED ORTHOPEDICS, INC.

00195377168276 - PRECICE Screws2024-01-19 5.0 mm X 100 mm Locking Screw, Fully Threaded
00195377168283 - PRECICE Screws2024-01-19 5.0 mm X 95 mm Locking Screw, Fully Threaded
00195377168290 - PRECICE Screws2024-01-19 5.0 mm X 80 mm Locking Screw, Fully Threaded
00195377168603 - PRECICE Screws2024-01-19 5.0 mm X 70 mm Locking Screw, Fully Threaded
00195377168610 - PRECICE Screws2024-01-19 5.0 mm X 60 mm Locking Screw, Fully Threaded
00195377168627 - PRECICE Screws2024-01-19 5.0 mm X 50 mm Locking Screw, Fully Threaded
00195377168634 - PRECICE Screws2024-01-19 5.0 mm X 45 mm Locking Screw, Fully Threaded
00195377168641 - PRECICE Screws2024-01-19 5.0 mm X 32.5 mm Locking Screw, Fully Threaded

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