Sypher ALIF Spacer System SAS-38291412

GUDID 00812593020293

Sypher Spacer - 38mm X 29mm X 14mm X 12°

BIOGENNIX LLC

Polymeric spinal fusion cage, sterile
Primary Device ID00812593020293
NIH Device Record Key821e9712-5fc3-49fd-bcc4-c4f899f70e1e
Commercial Distribution StatusIn Commercial Distribution
Brand NameSypher ALIF Spacer System
Version Model NumberSAS-38291412
Catalog NumberSAS-38291412
Company DUNS021486533
Company NameBIOGENNIX 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 Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Width38 Millimeter
Width38 Millimeter
Width38 Millimeter
Width38 Millimeter
Width38 Millimeter
Width38 Millimeter
Width38 Millimeter
Width38 Millimeter
Angle12 degree
Height14 Millimeter
Depth29 Millimeter
Width38 Millimeter
Angle12 degree
Height14 Millimeter
Depth29 Millimeter
Width38 Millimeter
Angle12 degree
Height14 Millimeter
Depth29 Millimeter
Width38 Millimeter
Angle12 degree
Height14 Millimeter
Depth29 Millimeter
Width38 Millimeter
Angle12 degree
Height14 Millimeter
Depth29 Millimeter
Width38 Millimeter
Angle12 degree
Height14 Millimeter
Depth29 Millimeter
Width38 Millimeter
Angle12 degree
Height14 Millimeter
Depth29 Millimeter
Width38 Millimeter
Angle12 degree
Height14 Millimeter
Depth29 Millimeter
Width38 Millimeter
Angle12 degree
Height14 Millimeter
Depth29 Millimeter
Width38 Millimeter
Angle12 degree
Height14 Millimeter
Depth29 Millimeter
Width38 Millimeter
Angle12 degree
Height14 Millimeter
Depth29 Millimeter
Width38 Millimeter
Angle12 degree
Height14 Millimeter
Depth29 Millimeter
Width38 Millimeter
Angle12 degree
Height14 Millimeter
Depth29 Millimeter
Width38 Millimeter
Angle12 degree
Height14 Millimeter
Depth29 Millimeter
Width38 Millimeter
Angle12 degree
Height14 Millimeter
Depth29 Millimeter
Width38 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100812593020293 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral Fusion Device With Bone Graft, Lumbar

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 Date2016-12-19

On-Brand Devices [Sypher ALIF Spacer System]

00812593020569Sypher Bone Screw - 6.0mm Diameter X 35mm Length
00812593020552Sypher Bone Screw - 6.0mm Diameter X 30mm Length
00812593020545Sypher Bone Screw - 6.0mm Diameter X 25mm Length
00812593020538Sypher Bone Screw - 5.5mm Diameter X 35mm Length
00812593020521Sypher Bone Screw - 5.5mm Diameter X 30mm Length
00812593020514Sypher Bone Screw - 5.5mm Diameter X 25mm Length
00812593020507Sypher Bone Screw - 5.0mm Diameter X 35mm Length
00812593020491Sypher Bone Screw - 5.0mm Diameter X 30mm Length
00812593020484Sypher Bone Screw - 5.0mm Diameter X 25mm Length
00812593020330Sypher Locking Cover Plate - 32mm X 12mm. Prohibits Bone Screw backout after implantation.
00812593020323Sypher Locking Cover Plate - 28mm X 12mm. Prohibits Bone Screw backout after implantation.
00812593020316Sypher Spacer - 38mm X 29mm X 18mm X 12°
00812593020309Sypher Spacer - 38mm X 29mm X 16mm X 12°
00812593020293Sypher Spacer - 38mm X 29mm X 14mm X 12°
00812593020286Sypher Spacer - 38mm X 29mm X 12mm X 12°
00812593020279Sypher Spacer - 38mm X 29mm X 18mm X 7°
00812593020262Sypher Spacer - 38mm X 29mm X 16mm X 7°
00812593020255Sypher Spacer - 38mm X 29mm X 14mm X 7°
00812593020248Sypher Spacer - 38mm X 29mm X 12mm X 7°
00812593020231Sypher Spacer - 35mm X 26mm X 18mm X 12°
00812593020224Sypher Spacer - 35mm X 26mm X 16mm X 12°
00812593020217Sypher Spacer - 35mm X 26mm X 14mm X 12°
00812593020200Sypher Spacer - 35mm X 26mm X 12mm X 12°
00812593020194Sypher Spacer - 35mm X 26mm X 18mm X 7°
00812593020187Sypher Spacer - 35mm X 26mm X 16mm X 7°
00812593020170Sypher Spacer - 35mm X 26mm X 14mm X 7°
00812593020163Sypher Spacer - 35mm X 26mm X 12mm X 7°
00812593020156Sypher Spacer - 32mm X 26mm X 18mm X 12°
00812593020149Sypher Spacer - 32mm X 26mm X 16mm X 12°
00812593020132Sypher Spacer - 32mm X 26mm X 14mm X 12°
00812593020125Sypher Spacer - 32mm X 26mm X 12mm X 12°
00812593020118Sypher Spacer - 32mm X 26mm X 18mm X 7°
00812593020101Sypher Spacer - 32mm X 26mm X 16mm X 7°
00812593020095Sypher Spacer - 32mm X 26mm X 14mm X 7°
00812593020088Sypher Spacer - 32mm X 26mm X 12mm X 7°
00812593020071Sypher Spacer - 28mm X 24mm X 18mm X 12°
00812593020064Sypher Spacer - 28mm X 24mm X 16mm X 12°
00812593020057Sypher Spacer - 28mm X 24mm X 14mm X 12°
00812593020040Sypher Spacer - 28mm X 24mm X 12mm X 12°
00812593020033Sypher Spacer - 28mm X 24mm X 18mm X 7°
00812593020026Sypher Spacer - P/N 1239-103 - 28mm X 24mm X 16mm X 7°
00812593020019Sypher Spacer - 28mm X 24mm X 14mm X 7°
00812593020002Sypher Spacer - 28mm X 24mm X 12mm X 7°

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