ORION WEDGE HTR-04-224310

GUDID 00841742142159

ORION Ti PEEK EVANS Wedge - 22x22x10mm

HNM TOTAL RECON LLC

Polymeric osteotomy fusion cage
Primary Device ID00841742142159
NIH Device Record Key8bfb28b6-739f-48c8-93ee-14012aec2c15
Commercial Distribution StatusIn Commercial Distribution
Brand NameORION WEDGE
Version Model NumberHTR-04-224310
Catalog NumberHTR-04-224310
Company DUNS080024940
Company NameHNM TOTAL RECON LLC
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100841742142159 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PLFBone Wedge

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 Date2017-06-30

On-Brand Devices [ORION WEDGE]

00841742142227ORION Ti PEEK COTTON Wedge - 20x14x6.5mm
00841742142210ORION Ti PEEK COTTON Wedge - 20x14x5.5mm
00841742142203ORION Ti PEEK COTTON Wedge - 20x14x4.5mm
00841742142197ORION Ti PEEK COTTON Wedge - 16x14x6.5mm
00841742142180ORION Ti PEEK COTTON Wedge - 16x14x5.5mm
00841742142173ORION Ti PEEK COTTON Wedge - 16x14x4.5mm
00841742142166ORION Ti PEEK EVANS Wedge - 22x22x12mm
00841742142159ORION Ti PEEK EVANS Wedge - 22x22x10mm
00841742142142ORION Ti PEEK EVANS Wedge - 22x22x8mm
00841742140964ORION Ti PEEK EVANS Wedge - 20x20x12mm
00841742124469ORION Ti PEEK EVANS Wedge - 20x20x10mm
00841742124452ORION Ti PEEK EVANS Wedge - 20x20x8mm
00841742124445ORION Ti PEEK EVANS Wedge - 18x18x12mm
00841742124438ORION Ti PEEK EVANS Wedge - 18x18x10mm
00841742124414ORION Ti PEEK EVANS Wedge - 18x18x8mm

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