Sypher ALIF Spacer System SAS-28241607

GUDID 00812593020026

Sypher Spacer - P/N 1239-103 - 28mm X 24mm X 16mm X 7°

BIOGENNIX LLC

Polymeric spinal fusion cage, sterile

Primary Device ID	00812593020026
NIH Device Record Key	ed076d6d-1963-4b1f-90d4-4c13470d8263
Commercial Distribution Status	In Commercial Distribution
Brand Name	Sypher ALIF Spacer System
Version Model Number	SAS-28241607
Catalog Number	SAS-28241607
Company DUNS	021486533
Company Name	BIOGENNIX LLC
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	true
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Dimensions

Width	28 Millimeter
Width	28 Millimeter
Width	28 Millimeter
Width	28 Millimeter
Width	28 Millimeter
Width	28 Millimeter
Width	28 Millimeter
Width	28 Millimeter
Angle	7 degree
Height	16 Millimeter
Depth	24 Millimeter
Width	28 Millimeter
Angle	7 degree
Height	16 Millimeter
Depth	24 Millimeter
Width	28 Millimeter
Angle	7 degree
Height	16 Millimeter
Depth	24 Millimeter
Width	28 Millimeter
Angle	7 degree
Height	16 Millimeter
Depth	24 Millimeter
Width	28 Millimeter
Angle	7 degree
Height	16 Millimeter
Depth	24 Millimeter
Width	28 Millimeter
Angle	7 degree
Height	16 Millimeter
Depth	24 Millimeter
Width	28 Millimeter
Angle	7 degree
Height	16 Millimeter
Depth	24 Millimeter
Width	28 Millimeter
Angle	7 degree
Height	16 Millimeter
Depth	24 Millimeter
Width	28 Millimeter
Angle	7 degree
Height	16 Millimeter
Depth	24 Millimeter
Width	28 Millimeter
Angle	7 degree
Height	16 Millimeter
Depth	24 Millimeter
Width	28 Millimeter
Angle	7 degree
Height	16 Millimeter
Depth	24 Millimeter
Width	28 Millimeter
Angle	7 degree
Height	16 Millimeter
Depth	24 Millimeter
Width	28 Millimeter
Angle	7 degree
Height	16 Millimeter
Depth	24 Millimeter
Width	28 Millimeter
Angle	7 degree
Height	16 Millimeter
Depth	24 Millimeter
Width	28 Millimeter
Angle	7 degree
Height	16 Millimeter
Depth	24 Millimeter
Width	28 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812593020026 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K141798

FDA Product Code

MAX	Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2018-07-06
Device Publish Date	2016-12-19

On-Brand Devices [Sypher ALIF Spacer System]

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