PRECICE Screws TSA5-095

GUDID 00195377168283

5.0 mm X 95 mm Locking Screw, Fully Threaded

NUVASIVE SPECIALIZED ORTHOPEDICS, INC.

Long bone distraction nail, magnetic Long bone distraction nail, magnetic Long bone distraction nail, magnetic Long bone distraction nail, magnetic Long bone distraction nail, magnetic Long bone distraction nail, magnetic Long bone distraction nail, magnetic Long bone distraction nail, magnetic Long bone distraction nail, magnetic Long bone distraction nail, magnetic Long bone distraction nail, magnetic Long bone distraction nail, magnetic Long bone distraction nail, magnetic Long bone distraction nail, magnetic Long bone distraction nail, magnetic Long bone distraction nail, magnetic Long bone distraction nail, magnetic Long bone distraction nail, magnetic
Primary Device ID00195377168283
NIH Device Record Key8c66ca92-90bd-45f8-9e62-703a28d0f977
Commercial Distribution Discontinuation2024-01-18
Commercial Distribution StatusNot in Commercial Distribution
Brand NamePRECICE Screws
Version Model NumberTSA5-095
Catalog NumberTSA5-095
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 Datefalse
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
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 Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100195377168283 [Primary]

FDA Product Code

HSBRod, Fixation, Intramedullary And Accessories

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00195377168283]

Moist Heat or Steam Sterilization


[00195377168283]

Moist Heat or Steam Sterilization


[00195377168283]

Moist Heat or Steam Sterilization


[00195377168283]

Moist Heat or Steam Sterilization


[00195377168283]

Moist Heat or Steam Sterilization


[00195377168283]

Moist Heat or Steam Sterilization


[00195377168283]

Moist Heat or Steam Sterilization


[00195377168283]

Moist Heat or Steam Sterilization


[00195377168283]

Moist Heat or Steam Sterilization


[00195377168283]

Moist Heat or Steam Sterilization


[00195377168283]

Moist Heat or Steam Sterilization


[00195377168283]

Moist Heat or Steam Sterilization


[00195377168283]

Moist Heat or Steam Sterilization


[00195377168283]

Moist Heat or Steam Sterilization


[00195377168283]

Moist Heat or Steam Sterilization


[00195377168283]

Moist Heat or Steam Sterilization


[00195377168283]

Moist Heat or Steam Sterilization


[00195377168283]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2024-01-19
Device Publish Date2017-10-09

On-Brand Devices [PRECICE Screws]

008875170010785.0 mm X 100 mm Locking Screw, Peg
008875170010615.0 mm X 95 mm Locking Screw, Peg
008875170010545.0 mm X 90 mm Locking Screw, Peg
008875170010475.0 mm X 85 mm Locking Screw, Peg
008875170010305.0 mm X 80 mm Locking Screw, Peg
008875170010234.0 mm X 100 mm Locking Screw, Peg
008875170010164.0 mm X 95 mm Locking Screw, Peg
008875170010094.0 mm X 90 mm Locking Screw, Peg
008875170009964.0 mm X 85 mm Locking Screw, Peg
008875170009894.0 mm X 80 mm Locking Screw, Peg
008875170009724.0 mm X 75 mm Locking Screw, Peg
008875170009654.0 mm X 70 mm Locking Screw, Peg
008875170009584.0 mm X 65 mm Locking Screw, Peg
008875170009415.0 mm X 100 mm Locking Screw, Partially Threaded
008875170009345.0 mm X 95 mm Locking Screw, Partially Threaded
008875170009275.0 mm X 90 mm Locking Screw, Partially Threaded
008875170009105.0 mm X 85 mm Locking Screw, Partially Threaded
008875170009035.0 mm X 80 mm Locking Screw, Partially Threaded
008875170008975.0 mm X 75 mm Locking Screw, Partially Threaded
008875170008805.0 mm X 70 mm Locking Screw, Partially Threaded
008875170008735.0 mm X 65 mm Locking Screw, Partially Threaded
008875170008665.0 mm X 60 mm Locking Screw, Partially Threaded
008875170008595.0 mm X 55 mm Locking Screw, Partially Threaded
008875170008425.0 mm X 50 mm Locking Screw, Partially Threaded
008875170008355.0 mm X 47.5 mm Locking Screw, Partially Threaded
008875170008285.0 mm X 45 mm Locking Screw, Partially Threaded
008875170008115.0 mm X 42.5 mm Locking Screw, Partially Threaded
008875170008045.0 mm X 40 mm Locking Screw, Partially Threaded
008875170007985.0 mm X 37.5 mm Locking Screw, Partially Threaded
008875170007815.0 mm X 35 mm Locking Screw, Partially Threaded
008875170007745.0 mm X 32.5 mm Locking Screw, Partially Threaded
008875170007675.0 mm X 30 mm Locking Screw, Partially Threaded
008875170007505.0 mm X 27.5 mm Locking Screw, Partially Threaded
008875170007435.0 mm X 25 mm Locking Screw, Partially Threaded
008875170007365.0 mm X 22.5 mm Locking Screw, Partially Threaded
008875170007295.0 mm X 20 mm Locking Screw, Partially Threaded
008875170007124.0 mm X 100 mm Locking Screw, Partially Threaded
008875170007054.0 mm X 95 mm Locking Screw, Partially Threaded
008875170006994.0 mm X 90 mm Locking Screw, Partially Threaded
008875170006824.0 mm X 85 mm Locking Screw, Partially Threaded
008875170006754.0 mm X 80 mm Locking Screw, Partially Threaded
008875170006684.0 mm X 75 mm Locking Screw, Partially Threaded
008875170006514.0 mm X 70 mm Locking Screw, Partially Threaded
008875170006444.0 mm X 65 mm Locking Screw, Partially Threaded
008875170006374.0 mm X 60 mm Locking Screw, Partially Threaded
008875170006204.0 mm X 55 mm Locking Screw, Partially Threaded
008875170006134.0 mm X 50 mm Locking Screw, Partially Threaded
008875170006064.0 mm X 47.5 mm Locking Screw, Partially Threaded
008875170005904.0 mm X 45 mm Locking Screw, Partially Threaded
008875170005834.0 mm X 42.5 mm Locking Screw, Partially Threaded

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.