ALLY Bone Screw PD-32-301

GUDID 00852776006027

The ALLY Bone Screw is a single-use implant made of titanium alloy and used in bone reconstruction, osteotomy, arthrodesis, join fusion, fracture repair and fixation appropriate for the size of the device.

PROVIDENCE MEDICAL TECHNOLOGY, INC.

Spinal dynamic-stabilization system

• Primary Device ID: 00852776006027
• NIH Device Record Key: c557da49-8eed-4f8d-ba02-41102e16f35b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ALLY Bone Screw
• Version Model Number: PD-32-301
• Catalog Number: PD-32-301
• Company DUNS: 969820245
• Company Name: PROVIDENCE MEDICAL TECHNOLOGY, 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: 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 Identifiers

Device Issuing Agency	Device ID
GS1	00852776006027 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121713

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

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

[00852776006027]

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[00852776006027]

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[00852776006027]

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[00852776006027]

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[00852776006027]

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[00852776006027]

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[00852776006027]

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[00852776006027]

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[00852776006027]

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[00852776006027]

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[00852776006027]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-03-29
• Device Publish Date: 2015-09-02

Devices Manufactured by PROVIDENCE MEDICAL TECHNOLOGY, INC.

• 00852776006478 - CORUS-LX Implant, 4mm: 2025-08-21 The CAVUX Cage-LX is used in conjunction with ALLY Bone ScrewLX as an integrated construct referred to as the CORUS-LX Implant.
• 00852776006539 - CORUS-LX Implant, 5mm: 2025-08-21 The CAVUX Cage-LX is used in conjunction with ALLY Bone ScrewLX as an integrated construct referred to as the CORUS-LX Implant
• 00852776006546 - CORUS-LX LevelOne, 4mm: 2025-08-21 Three related devices: CORUS-LX Implant, CORUS Spinal System-LX and DiViNE Portal System-LX, referred to as “CORUS-LX LevelO
• 00852776006577 - CAVUX Cage-LX, 5mm: 2025-07-16 The CAVUX Cage-LX is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine
• 00852776006645 - CORUS PCSS Implant 4mm: 2025-02-27 CORUS™ PCSS is posterior spinal instrumentation with integrated screw fixation intended to provide immobilization and stabiliz
• 00852776006676 - CORUS PCSS Implant, 5mm: 2025-02-27 CORUS™ PCSS is posterior spinal instrumentation with integrated screw fixation intended to provide immobilization and stabiliz
• 00852776006683 - CORUS PCSS LevelOne, 4mm: 2025-02-27 Three related devices: CORUS PCSS Implant, CORUS Spinal System and DiViNE Portal System, referred to as “CORUS™ PCSS LevelO
• 00852776006447 - CAVUX CERVICAL CAGE-X, 5MM: 2024-11-21 CAVUX® Cervical Cages are titanium constructs offered in various footprints and heights. All CAVUX® Cervical Cages are manufac