OsseoScrew

GUDID 00844856026414

6.5mm Solid Tapered Polyaxial Tap

ALPHATEC SPINE, INC.

Manual surgical rotary handpiece

• Primary Device ID: 00844856026414
• NIH Device Record Key: a1f5c2f6-9619-4f71-84eb-179673fc09d5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OsseoScrew
• Version Model Number: 92910-65
• Company DUNS: 602465783
• Company Name: ALPHATEC SPINE, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• 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

Device Dimensions

• Outer Diameter: 6.5 Millimeter
• Outer Diameter: 6.5 Millimeter
• Outer Diameter: 6.5 Millimeter
• Outer Diameter: 6.5 Millimeter
• Outer Diameter: 6.5 Millimeter
• Outer Diameter: 6.5 Millimeter
• Outer Diameter: 6.5 Millimeter
• Outer Diameter: 6.5 Millimeter
• Outer Diameter: 6.5 Millimeter
• Outer Diameter: 6.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00844856026414 [Primary]

FDA Product Code

• HTW: BIT, DRILL

Sterilization

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

[00844856026414]

Moist Heat or Steam Sterilization

[00844856026414]

Moist Heat or Steam Sterilization

[00844856026414]

Moist Heat or Steam Sterilization

[00844856026414]

Moist Heat or Steam Sterilization

[00844856026414]

Moist Heat or Steam Sterilization

[00844856026414]

Moist Heat or Steam Sterilization

[00844856026414]

Moist Heat or Steam Sterilization

[00844856026414]

Moist Heat or Steam Sterilization

[00844856026414]

Moist Heat or Steam Sterilization

[00844856026414]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-01-07
• Device Publish Date: 2019-12-30

On-Brand Devices [OsseoScrew]

• 00844856051713: OSSEOSCREW DEPLOYMENT T-HANDLE
• 00844856051706: OSSEOSCREW UN-DEPLOY TOOL
• 00844856051683: OSSEOSCREW POLYAXIAL/HIGH TOP DRIVER
• 00844856051676: Osseoscrew Deployment Shaft, 40 mm
• 00844856051669: Osseoscrew Deployment Shaft, 45 mm
• 00844856051652: Osseoscrew Deployment Shaft, 50 mm
• 00844856051645: Osseoscrew Deployment Shaft, 55 mm
• 00844856051638: OSSEOSCREW TRIAL PROBE, RIGHT
• 00844856051621: OSSEOSCREW TRIAL PROBE, LEFT
• 00844856051584: OSSEOSCREW RETRIEVAL TOOL
• 00844856049192: OSSEOSCREW F TI POLYAXIAL 7.5 X 55MM
• 00844856049185: OSSEOSCREW F TI POLYAXIAL 7.5 X 50MM
• 00844856049178: OSSEOSCREW F TI POLYAXIAL 7.5 X 45MM
• 00844856049161: OSSEOSCREW F TI POLYAXIAL 7.5 X 40MM
• 00844856049154: OSSEOSCREW F TI POLYAXIAL 6.5 X 55MM
• 00844856049147: OSSEOSCREW F TI POLYAXIAL 6.5 X 50MM
• 00844856049130: OSSEOSCREW F TI POLYAXIAL 6.5 X 45MM
• 00844856049123: OSSEOSCREW F TI POLYAXIAL 6.5 X 40MM
• 00844856049116: OSSEOSCREW F TI HIGH TOP 7.5 X 55MM
• 00844856049109: OSSEOSCREW F TI HIGH TOP 7.5 X 50MM
• 00844856049093: OSSEOSCREW F TI HIGH TOP 7.5 X 45MM
• 00844856049086: OSSEOSCREW F TI HIGH TOP 7.5 X 40MM
• 00844856049079: OSSEOSCREW F TI HIGH TOP 6.5 X 55MM
• 00844856049062: OSSEOSCREW F TI HIGH TOP 6.5 X 50MM
• 00844856049055: OSSEOSCREW F TI HIGH TOP 6.5 X 45MM
• 00844856049048: OSSEOSCREW F TI HIGH TOP 6.5 X 40MM
• 00844856044685: Cannulated Anti-torque Standard/Hightop
• 00844856036406: Set Screw Driver
• 00844856032255: T-Handle Torque Wrench 100 In-Lbs
• 00844856026438: 7.5mm Solid Tapered Polyaxial Tap
• 00844856026414: 6.5mm Solid Tapered Polyaxial Tap
• 00844856026391: 5.5mm Solid Tapered Polyaxial Tap
• 00190376073095: OSSEOSCREW INSERTER INSTRUMENT
• 00844856051690: Osseoscrew Inserter Instrument
• 00190376276151: OSSEOSCREW INSTRUMENT SET
• 00190376276144: OSSEOSCREW IMPLANT SET