Lotus

GUDID 08406061015854

Ø4.5mm X 10mm Polyaxial Screw

SPINAL ELEMENTS, INC.

Spinal bone screw, non-bioabsorbable

• Primary Device ID: 08406061015854
• NIH Device Record Key: e83b1296-e2ac-4d13-81e0-27b26d481841
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lotus
• Version Model Number: 32545-010
• Company DUNS: 610712213
• Company Name: SPINAL ELEMENTS, INC.
• Device Count: 1
• DM Exempt: true
• 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: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1 (760) 607 0121
• Email: info@spinalelements.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08406061015854 [Primary]

FDA Product Code

• KWP: Appliance, Fixation, Spinal Interlaminal

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[08406061015854]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-04-09
• Device Publish Date: 2019-02-18

On-Brand Devices [Lotus]

• 08406061016097: Offset Connector, 15mm
• 08406061016073: Offset Connector, 11mm
• 08406061016059: Hook, 5mm Right Angled
• 08406061016042: Hook, 5mm Left Angled
• 08406061016035: Hook, 6mm Straight
• 08406061016028: Hook, 5mm Straight
• 08406061016011: Hook, 4mm Straight
• 08406061016004: Ø4.5mm X 40mm Polyaxial Screw
• 08406061015991: Ø4.5mm X 38mm Polyaxial Screw
• 08406061015984: Ø4.5mm X 36mm Polyaxial Screw
• 08406061015977: Ø4.5mm X 34mm Polyaxial Screw
• 08406061015960: Ø4.5mm X 32mm Polyaxial Screw
• 08406061015953: Ø4.5mm X 30mm Polyaxial Screw
• 08406061015946: Ø4.5mm X 28mm Polyaxial Screw
• 08406061015939: Ø4.5mm X 26mm Polyaxial Screw
• 08406061015922: Ø4.5mm X 24mm Polyaxial Screw
• 08406061015915: Ø4.5mm X 22mm Polyaxial Screw
• 08406061015908: Ø4.5mm X 20mm Polyaxial Screw
• 08406061015892: Ø4.5mm X 18mm Polyaxial Screw
• 08406061015885: Ø4.5mm X 16mm Polyaxial Screw
• 08406061015878: Ø4.5mm X 14mm Polyaxial Screw
• 08406061015861: Ø4.5mm X 12mm Polyaxial Screw
• 08406061015854: Ø4.5mm X 10mm Polyaxial Screw
• 08406061007743: Ø5.5MM PARALLEL ROD TO ROD CONNECTOR
• 08406061007736: Ø5.5MM AXIAL ROD TO ROD CONNECTOR
• 08406061007729: Offset Connector 15MM
• 08406061007712: Offset Connector 13MM
• 08406061007705: Offset Connector 11MM
• 08406061007699: Offset Connector 9MM
• 08406061007682: Threaded Cap
• 08406061007675: Ø4.0mm X 38mm Polyaxial Screw 18mm Smooth Shank
• 08406061007668: Ø4.0mm X 35mm Polyaxial Screw 17mm Smooth Shank
• 08406061007651: Ø4.0mm X 42mm Polyaxial Screw 16mm Smooth Shank
• 08406061007644: Ø4.0mm X 40mm Polyaxial Screw 16mm Smooth Shank
• 08406061007637: Ø4.0mm X 37mm Polyaxial Screw 15mm Smooth Shank
• 08406061007620: Ø4.0mm X 35mm Polyaxial Screw 15mm Smooth Shank
• 08406061007613: Ø4.0mm X 32mm Polyaxial Screw 14mm Smooth Shank
• 08406061007606: Ø4.0mm X 30mm Polyaxial Screw 14mm Smooth Shank
• 08406061007590: Ø4.0mm X 39mm Polyaxial Screw 13mm Smooth Shank
• 08406061007583: Ø4.0mm X 37mm Polyaxial Screw 13mm Smooth Shank
• 08406061007576: Ø4.0mm X 34mm Polyaxial Screw 12mm Smooth Shank
• 08406061007569: Ø4.0mm X 32mm Polyaxial Screw 12mm Smooth Shank
• 08406061007552: Ø4.0mm X 32mm Polyaxial Screw 11mm Smooth Shank
• 08406061007545: Ø4.0mm X 30mm Polyaxial Screw 11mm Smooth Shank
• 08406061007538: Ø4.0mm X 29mm Polyaxial Screw 11mm Smooth Shank
• 08406061007521: Ø4.0mm X 28mm Polyaxial Screw 11mm Smooth Shank
• 08406061007514: Ø4.0mm X 27mm Polyaxial Screw 11mm Smooth Shank
• 08406061007507: Ø4.0mm X 36mm Polyaxial Screw 10mm Smooth Shank
• 08406061007491: Ø4.0mm X 34mm Polyaxial Screw 10mm Smooth Shank
• 08406061007484: Ø4.0mm X 31mm Polyaxial Screw 9mm Smooth Shank