Screw, Cannulated,7.0x175mm, 16mm Thread 431-269-175

GUDID 00846468041960

Screw, Cannulated,7.0x175mm, 16mm Thread

Pioneer Surgical Technology, Inc.

Orthopaedic bone screw, non-bioabsorbable, non-sterile
Primary Device ID00846468041960
NIH Device Record Key82b834ea-3696-48f1-9365-b88acc98d280
Commercial Distribution StatusIn Commercial Distribution
Brand NameScrew, Cannulated,7.0x175mm, 16mm Thread
Version Model Number431-269-175
Catalog Number431-269-175
Company DUNS793384496
Company NamePioneer Surgical Technology, Inc.
Device Count1
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100846468041960 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OURSacroiliac joint fixation

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00846468041960]

Moist Heat or Steam Sterilization


[00846468041960]

Moist Heat or Steam Sterilization


[00846468041960]

Moist Heat or Steam Sterilization


[00846468041960]

Moist Heat or Steam Sterilization


[00846468041960]

Moist Heat or Steam Sterilization


[00846468041960]

Moist Heat or Steam Sterilization


[00846468041960]

Moist Heat or Steam Sterilization


[00846468041960]

Moist Heat or Steam Sterilization


[00846468041960]

Moist Heat or Steam Sterilization


[00846468041960]

Moist Heat or Steam Sterilization


[00846468041960]

Moist Heat or Steam Sterilization


[00846468041960]

Moist Heat or Steam Sterilization


[00846468041960]

Moist Heat or Steam Sterilization


[00846468041960]

Moist Heat or Steam Sterilization


[00846468041960]

Moist Heat or Steam Sterilization


[00846468041960]

Moist Heat or Steam Sterilization


[00846468041960]

Moist Heat or Steam Sterilization


[00846468041960]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-12-10

Devices Manufactured by Pioneer Surgical Technology, Inc.

00191083033211 - Cross-Fuse® II PEEK IBF System2024-12-20 IMPLANT FORK
00840298704248 - CODA™ Anterior Cervical Plate System2024-10-28 3 Level Template
00840298704255 - CODA™ Anterior Cervical Plate System2024-10-28 3 Level Template
00840298704262 - CODA™ Anterior Cervical Plate System2024-10-28 4 Level Template
00840298704279 - CODA™ Anterior Cervical Plate System2024-10-28 5 Level Template
00840298704750 - CODA™ Anterior Cervical Plate System2024-10-28 Plate Caddy
00840298704200 - CODA™ Anterior Cervical Plate System2024-10-25 3 Level Plate
00840298704217 - CODA™ Anterior Cervical Plate System2024-10-25 3 Level Plate

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