HXA0005

GUDID 00860161000376

SURGICAL PLANNING ASSOC INC

Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable
Primary Device ID00860161000376
NIH Device Record Key3cd5200d-c88e-4358-8301-d052709d6df1
Commercial Distribution StatusIn Commercial Distribution
Brand NameHXA0005
Version Model NumberHXA0005
Company DUNS606309636
Company NameSURGICAL PLANNING ASSOC INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100860161000376 [Primary]

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00860161000376]

Moist Heat or Steam Sterilization


[00860161000376]

Moist Heat or Steam Sterilization


[00860161000376]

Moist Heat or Steam Sterilization


[00860161000376]

Moist Heat or Steam Sterilization


[00860161000376]

Moist Heat or Steam Sterilization


[00860161000376]

Moist Heat or Steam Sterilization


[00860161000376]

Moist Heat or Steam Sterilization


[00860161000376]

Moist Heat or Steam Sterilization


[00860161000376]

Moist Heat or Steam Sterilization


[00860161000376]

Moist Heat or Steam Sterilization


[00860161000376]

Moist Heat or Steam Sterilization


[00860161000376]

Moist Heat or Steam Sterilization


[00860161000376]

Moist Heat or Steam Sterilization


[00860161000376]

Moist Heat or Steam Sterilization


[00860161000376]

Moist Heat or Steam Sterilization


[00860161000376]

Moist Heat or Steam Sterilization


[00860161000376]

Moist Heat or Steam Sterilization


[00860161000376]

Moist Heat or Steam Sterilization


[00860161000376]

Moist Heat or Steam Sterilization


[00860161000376]

Moist Heat or Steam Sterilization


[00860161000376]

Moist Heat or Steam Sterilization


[00860161000376]

Moist Heat or Steam Sterilization


[00860161000376]

Moist Heat or Steam Sterilization


[00860161000376]

Moist Heat or Steam Sterilization


[00860161000376]

Moist Heat or Steam Sterilization


[00860161000376]

Moist Heat or Steam Sterilization


[00860161000376]

Moist Heat or Steam Sterilization


[00860161000376]

Moist Heat or Steam Sterilization


[00860161000376]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-11-03
Device Publish Date2022-10-26

Devices Manufactured by SURGICAL PLANNING ASSOC INC

00860161000369 - HipXpert HXA0003B kit2023-05-03
00860161000383 - HX0006 tracker Tray2023-05-03
00860161000352 - Hipxpert HX0002B2023-02-16
00860161000376 - HXA00052022-11-03
00860161000376 - HXA00052022-11-03
00860161000338 - Hipxpert HX00042022-10-19 Hipxpert/Insight Lateral kit with tracker tray Instrument System

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