Solanas

GUDID 00844856007161

POLYAXIAL POSTERIOR THORACIC SCREW, Ø4.35mm X 36mm

ALPHATEC SPINE, INC.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00844856007161
• NIH Device Record Key: 966739a3-d6dc-46b8-982a-9e883a70a6ac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Solanas
• Version Model Number: 63043-36
• Company DUNS: 602465783
• Company Name: ALPHATEC SPINE, 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: false
• 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)431-9286
• Email: Regulatory@alphatecspine.com

Device Dimensions

• Length: 36 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00844856007161 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173522

FDA Product Code

• KWP: APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Sterilization

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

[00844856007161]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-07-01
• Device Publish Date: 2020-06-23

On-Brand Devices [Solanas]

• 00844856007185: POLYAXIAL POSTERIOR THORACIC SCREW, Ø4.35mm X 44mm
• 00844856007178: POLYAXIAL POSTERIOR THORACIC SCREW, Ø4.35mm X 40mm
• 00844856007161: POLYAXIAL POSTERIOR THORACIC SCREW, Ø4.35mm X 36mm
• 00844856007147: POLYAXIAL POSTERIOR THORACIC SCREW, Ø4.35mm X 28mm
• 00844856007130: POLYAXIAL POSTERIOR THORACIC SCREW, Ø4.35mm X 24mm
• 00844856007123: POLYAXIAL POSTERIOR THORACIC SCREW, Ø4.35mm X 20mm
• 00844856007116: POLYAXIAL POSTERIOR THORACIC SCREW, Ø4.35mm X 16mm
• 00844856007697: 3.0mm ROD TEMPLATE, 15cm
• 00190376276274: SOLANAS REV 3 IMPLANTS AND INSTRUMENTS
• 00844856007543: CERVICAL HOOK HOLDER
• 00844856007536: CERVICAL HOOK TRIAL
• 00844856000049: SMALL DEPTH GAUGE 2.7/4.0
• 00844856007581: THORACIC SCREW BONE AWL
• 00844856026933: THORACIC TAP, 4.35mm
• 00844856026926: THORACIC TAP, 3.0mm
• 00844856007512: THORACIC TAP, 4.0mm
• 00844856007505: THORACIC TAP, 3.5mm
• 00844856007901: ADJUSTABLE DRILL SLEEVE