REFORM 39-RU-5540

GUDID 00815362029589

Reform Uniplanar Screw 5.5 x 40MM (QTY 108)

PRECISION SPINE, INC.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00815362029589
• NIH Device Record Key: c08eeb34-a1d9-48d0-945e-7adc53d128cc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: REFORM
• Version Model Number: 0634BG
• Catalog Number: 39-RU-5540
• Company DUNS: 079398589
• Company Name: PRECISION 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815362029589 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121172

FDA Product Code

• MNI: Orthosis, Spinal Pedicle Fixation

Sterilization

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

[00815362029589]

Moist Heat or Steam Sterilization

[00815362029589]

Moist Heat or Steam Sterilization

[00815362029589]

Moist Heat or Steam Sterilization

[00815362029589]

Moist Heat or Steam Sterilization

[00815362029589]

Moist Heat or Steam Sterilization

[00815362029589]

Moist Heat or Steam Sterilization

[00815362029589]

Moist Heat or Steam Sterilization

[00815362029589]

Moist Heat or Steam Sterilization

[00815362029589]

Moist Heat or Steam Sterilization

[00815362029589]

Moist Heat or Steam Sterilization

[00815362029589]

Moist Heat or Steam Sterilization

[00815362029589]

Moist Heat or Steam Sterilization

[00815362029589]

Moist Heat or Steam Sterilization

[00815362029589]

Moist Heat or Steam Sterilization

[00815362029589]

Moist Heat or Steam Sterilization

[00815362029589]

Moist Heat or Steam Sterilization

[00815362029589]

Moist Heat or Steam Sterilization

[00815362029589]

Moist Heat or Steam Sterilization

[00815362029589]

Moist Heat or Steam Sterilization

[00815362029589]

Moist Heat or Steam Sterilization

[00815362029589]

Moist Heat or Steam Sterilization

[00815362029589]

Moist Heat or Steam Sterilization

[00815362029589]

Moist Heat or Steam Sterilization

[00815362029589]

Moist Heat or Steam Sterilization

[00815362029589]

Moist Heat or Steam Sterilization

[00815362029589]

Moist Heat or Steam Sterilization

[00815362029589]

Moist Heat or Steam Sterilization

[00815362029589]

Moist Heat or Steam Sterilization

[00815362029589]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-12-06

On-Brand Devices [REFORM ]

• 00815362029992: Reform Polyaxial Screw 8.5 x 55MM (QTY 85)
• 00815362029985: Reform Polyaxial Screw 8.5 x 50MM (QTY 38)
• 00815362029978: Reform Polyaxial Screw 8.5 x 50MM (QTY 101)
• 00815362029961: Reform Polyaxial Screw 7.5 x 55MM (QTY 120)
• 00815362029954: Reform Polyaxial Screw 7.5 x 55MM (QTY 42)
• 00815362029947: Reform Polyaxial Screw 7.5 x 55MM (QTY 24 )
• 00815362029930: Reform Polyaxial Screw 7.5 x 50MM (QTY200 )
• 00815362029923: Reform Polyaxial Screw 7.5 x 40MM (QTY 239)
• 00815362029916: Reform Polyaxial Screw 6.5 x 55MM (QTY 226)
• 00815362029909: Reform Polyaxial Screw 6.5 x 55MM (QTY 101)
• 00815362029893: Reform Polyaxial Screw 6.5 x 55MM (QTY 79)
• 00815362029886: Reform Polyaxial Screw 6.5 x 55MM (QTY 98)
• 00815362029879: Reform Polyaxial Screw 6.5 x 50MM (QTY 276)
• 00815362029862: Reform Polyaxial Screw 6.5 x 50MM (QTY 250)
• 00815362029855: Reform Polyaxial Screw 6.5 x 50MM (QTY 200)
• 00815362029848: Reform Polyaxial Screw 6.5 x 50MM (QTY 101)
• 00815362029831: Reform Polyaxial Screw 6.5 x 35MM (QTY191 )
• 00815362029824: Reform Uniplanar Screw 6.5 x 30MM (QTY 100)
• 00815362029701: Reform Hex Rod End Rod 5.5mm (QTY 30)
• 00815362029695: Reform Hook Angled Hook, MD, Right (QTY 16)
• 00815362029688: Reform Uniplanar Screw 5.5 x 30mm (QTY 126)
• 00815362029671: Reform Uniplanar Screw 5.5 x 25mm (QTY 35)
• 00815362029657: Reform Uniplanar Screw 6.5 x 45MM (QTY 50)
• 00815362029640: Reform Uniplanar Screw 6.5.x40 MM (QTY 46 )
• 00815362029633: Reform Uniplanar Screw 6.5 x 40MM (QTY 100 )
• 00815362029626: Reform Uniplanar Screw 6.5 x 35MM (QTY 100)
• 00815362029619: Reform Uniplanar Screw 6.5 x 30MM (QTY 3)
• 00815362029602: Reform Uniplanar Screw 6.5 x 30MM (QTY 73)
• 00815362029596: Reform Uniplanar Screw 5.5 x 45MM (QTY 67)
• 00815362029589: Reform Uniplanar Screw 5.5 x 40MM (QTY 108)
• 00815362029572: Reform Uniplanar Screw 5.5 x 35MM (QTY98)
• 00815362029565: Reform Uniplanar Screw 5.5 x 35MM (QTY 98)
• 00815362029558: Reform Uniplanar Screw 5.5 x 30MM (QTY 26)
• 00815362029541: Reform Uniplanar Screw 5.5 x 30mm (Qty 40)
• 00815362029534: Reform Uniplanar Screw 4.5 x 40mm (Qty 25)
• 00815362029527: Reform Uniplanar Screw 4.5 x 35MM (QTY 39)
• 00815362029510: Reform Uniplanar Screw 4.5 x 30MM (QTY 40)
• 00815362029503: Reform Uniplanar Screw 4.5 X 25 mm (QTY 37)
• 00815362024034: REFORM LATERAL OFFSET 20mm (qty 9)