Sypher ALIF Spacer System SAS-5535

GUDID 00812593020538

Sypher Bone Screw - 5.5mm Diameter X 35mm Length

BIOGENNIX LLC

Spinal bone screw, non-bioabsorbable

• Primary Device ID: 00812593020538
• NIH Device Record Key: 397429a7-40b0-401f-8222-aaed0ff0e281
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sypher ALIF Spacer System
• Version Model Number: SAS-5535
• Catalog Number: SAS-5535
• 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

• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812593020538 [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: 4
• Public Version Date: 2019-04-09
• 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°