ALLY™ Bone Screw-L 12mm PD-32-602

GUDID 10852776006314

The bone screw is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation appropriate for the size of the device. screws are intended for single use only.

PROVIDENCE MEDICAL TECHNOLOGY, INC.

Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable

• Primary Device ID: 10852776006314
• NIH Device Record Key: 517bde3c-ccd8-4b84-91f3-874719e2497d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ALLY™ Bone Screw-L 12mm
• Version Model Number: PD-32-602
• Catalog Number: PD-32-602
• Company DUNS: 969820245
• Company Name: PROVIDENCE MEDICAL TECHNOLOGY, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: 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	00852776006317 [Primary]
GS1	10852776006314 [Package]; Contains: 00852776006317; Package: Box [1 Units]; In Commercial Distribution

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

[10852776006314]

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[10852776006314]

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[10852776006314]

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[10852776006314]

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[10852776006314]

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[10852776006314]

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[10852776006314]

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[10852776006314]

Radiation Sterilization

[10852776006314]

Radiation Sterilization

[10852776006314]

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[10852776006314]

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[10852776006314]

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[10852776006314]

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[10852776006314]

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[10852776006314]

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[10852776006314]

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[10852776006314]

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[10852776006314]

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[10852776006314]

Radiation Sterilization

[10852776006314]

Radiation Sterilization

[10852776006314]

Radiation Sterilization

[10852776006314]

Radiation Sterilization

[10852776006314]

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[10852776006314]

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[10852776006314]

Radiation Sterilization

[10852776006314]

Radiation Sterilization

[10852776006314]

Radiation Sterilization

[10852776006314]

Radiation Sterilization

[10852776006314]

Radiation Sterilization

[10852776006314]

Radiation Sterilization

[10852776006314]

Radiation Sterilization

[10852776006314]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-04-09
• Device Publish Date: 2016-09-27

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