Segmental Plating System

GUDID 00190376545844

SPS FA Self-Tap Screw, 3.5 x 20 mm

ALPHATEC SPINE, INC.

Spinal bone screw, non-bioabsorbable

• Primary Device ID: 00190376545844
• NIH Device Record Key: 40242f6d-c0d6-49ea-954c-9eb884f30a8c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Segmental Plating System
• Version Model Number: 338-1-33520
• 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
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com

Device Dimensions

• Outer Diameter: 3.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 20 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00190376545844 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233640

FDA Product Code

• KWQ: Appliance, fixation, spinal intervertebral body

Sterilization

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

[00190376545844]

Moist Heat or Steam Sterilization

[00190376545844]

Moist Heat or Steam Sterilization

[00190376545844]

Moist Heat or Steam Sterilization

[00190376545844]

Moist Heat or Steam Sterilization

[00190376545844]

Moist Heat or Steam Sterilization

[00190376545844]

Moist Heat or Steam Sterilization

[00190376545844]

Moist Heat or Steam Sterilization

[00190376545844]

Moist Heat or Steam Sterilization

[00190376545844]

Moist Heat or Steam Sterilization

[00190376545844]

Moist Heat or Steam Sterilization

[00190376545844]

Moist Heat or Steam Sterilization

[00190376545844]

Moist Heat or Steam Sterilization

[00190376545844]

Moist Heat or Steam Sterilization

[00190376545844]

Moist Heat or Steam Sterilization

[00190376545844]

Moist Heat or Steam Sterilization

[00190376545844]

Moist Heat or Steam Sterilization

[00190376545844]

Moist Heat or Steam Sterilization

[00190376545844]

Moist Heat or Steam Sterilization

[00190376545844]

Moist Heat or Steam Sterilization

[00190376545844]

Moist Heat or Steam Sterilization

[00190376545844]

Moist Heat or Steam Sterilization

[00190376545844]

Moist Heat or Steam Sterilization

[00190376545844]

Moist Heat or Steam Sterilization

[00190376545844]

Moist Heat or Steam Sterilization

[00190376545844]

Moist Heat or Steam Sterilization

[00190376545844]

Moist Heat or Steam Sterilization

[00190376545844]

Moist Heat or Steam Sterilization

[00190376545844]

Moist Heat or Steam Sterilization

[00190376545844]

Moist Heat or Steam Sterilization

[00190376545844]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-07-08
• Device Publish Date: 2024-06-28

On-Brand Devices [Segmental Plating System]

• 00190376588834: Segmental Plating System Core Set Configuration
• 00190376546094: SPS FA Self-Drill Screw, 3.5 x 19 mm
• 00190376546087: SPS FA Self-Drill Screw, 3.5 x 18 mm
• 00190376546070: SPS FA Self-Drill Screw, 3.5 x 17 mm
• 00190376546063: SPS FA Self-Drill Screw, 3.5 x 16 mm
• 00190376546056: SPS FA Self-Drill Screw, 3.5 x 15 mm
• 00190376546049: SPS FA Self-Drill Screw, 3.5 x 14 mm
• 00190376546032: SPS FA Self-Drill Screw, 3.5 x 13 mm
• 00190376546025: SPS FA Self-Drill Screw, 3.5 x 12 mm
• 00190376546018: SPS FA Self-Tap Screw, 4.0 x 24 mm
• 00190376546001: SPS FA Self-Tap Screw, 4.0 x 23 mm
• 00190376545998: SPS FA Self-Tap Screw, 4.0 x 22 mm
• 00190376545981: SPS FA Self-Tap Screw, 4.0 x 21 mm
• 00190376545974: SPS FA Self-Tap Screw, 4.0 x 20 mm
• 00190376545967: SPS FA Self-Tap Screw, 4.0 x 19 mm
• 00190376545950: SPS FA Self-Tap Screw, 4.0 x 18 mm
• 00190376545943: SPS FA Self-Tap Screw, 4.0 x 17 mm
• 00190376545936: SPS FA Self-Tap Screw, 4.0 x 16 mm
• 00190376545929: SPS FA Self-Tap Screw, 4.0 x 15 mm
• 00190376545912: SPS FA Self-Tap Screw, 4.0 x 14 mm
• 00190376545905: SPS FA Self-Tap Screw, 4.0 x 13 mm
• 00190376545899: SPS FA Self-Tap Screw, 4.0 x 12 mm
• 00190376545882: SPS FA Self-Tap Screw, 3.5 x 24 mm
• 00190376545875: SPS FA Self-Tap Screw, 3.5 x 23 mm
• 00190376545868: SPS FA Self-Tap Screw, 3.5 x 22 mm
• 00190376545851: SPS FA Self-Tap Screw, 3.5 x 21 mm
• 00190376545844: SPS FA Self-Tap Screw, 3.5 x 20 mm
• 00190376545837: SPS FA Self-Tap Screw, 3.5 x 19 mm
• 00190376545820: SPS FA Self-Tap Screw, 3.5 x 18 mm
• 00190376545813: SPS FA Self-Tap Screw, 3.5 x 17 mm
• 00190376545806: SPS FA Self-Tap Screw, 3.5 x 16 mm
• 00190376545790: SPS FA Self-Tap Screw, 3.5 x 15 mm
• 00190376545783: SPS FA Self-Tap Screw, 3.5 x 14 mm
• 00190376545776: SPS FA Self-Tap Screw, 3.5 x 13 mm
• 00190376545769: SPS FA Self-Tap Screw, 3.5 x 12 mm
• 00190376545752: SPS VA Self-Drill Screw, 4.0 x 24mm
• 00190376545745: SPS VA Self-Drill Screw, 4.0 x 23mm
• 00190376545738: SPS VA Self-Drill Screw, 4.0 x 22mm
• 00190376545721: SPS VA Self-Drill Screw, 4.0 x 21mm
• 00190376545714: SPS VA Self-Drill Screw, 4.0 x 20mm
• 00190376545707: SPS VA Self-Drill Screw, 4.0 x 19mm
• 00190376545691: SPS VA Self-Drill Screw, 4.0 x 18mm
• 00190376545684: SPS VA Self-Drill Screw, 4.0 x 17mm
• 00190376545677: SPS VA Self-Drill Screw, 4.0 x 16mm
• 00190376545660: SPS VA Self-Drill Screw, 4.0 x 15mm
• 00190376545653: SPS VA Self-Drill Screw, 4.0 x 14mm
• 00190376545646: SPS VA Self-Drill Screw, 4.0 x 13mm
• 00190376545639: SPS VA Self-Drill Screw, 4.0 x 12mm
• 00190376545622: SPS VA Self-Tap Screw, 4.0 x 24 mm
• 00190376545615: SPS VA Self-Tap Screw, 4.0 x 23 mm