Foot and Ankle Plating System 54-12S-10U

GUDID 00190837084974

10mm Calcaneal Step Plate

Life Spine, Inc.

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile

• Primary Device ID: 00190837084974
• NIH Device Record Key: 6a8a2113-7fef-40f4-8277-e053a87ee224
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Foot and Ankle Plating System
• Version Model Number: 54-12S-10U
• Catalog Number: 54-12S-10U
• Company DUNS: 183641617
• Company Name: Life Spine, Inc.
• Device Count: 1
• DM Exempt: false
• 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	00190837084974 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172973

FDA Product Code

• HRS: Plate, fixation, bone

Sterilization

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

[00190837084974]

Moist Heat or Steam Sterilization

[00190837084974]

Moist Heat or Steam Sterilization

[00190837084974]

Moist Heat or Steam Sterilization

[00190837084974]

Moist Heat or Steam Sterilization

[00190837084974]

Moist Heat or Steam Sterilization

[00190837084974]

Moist Heat or Steam Sterilization

[00190837084974]

Moist Heat or Steam Sterilization

[00190837084974]

Moist Heat or Steam Sterilization

[00190837084974]

Moist Heat or Steam Sterilization

[00190837084974]

Moist Heat or Steam Sterilization

[00190837084974]

Moist Heat or Steam Sterilization

[00190837084974]

Moist Heat or Steam Sterilization

[00190837084974]

Moist Heat or Steam Sterilization

[00190837084974]

Moist Heat or Steam Sterilization

[00190837084974]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-11-15
• Device Publish Date: 2019-11-07

On-Brand Devices [Foot and Ankle Plating System]

• 00190837084974: 10mm Calcaneal Step Plate
• 00190837084967: 9mm Calcaneal Step Plate
• 00190837084950: 8mm Calcaneal Step Plate
• 00190837084943: 7mm Calcaneal Step Plate
• 00190837084936: 6mm Calcaneal Step Plate
• 00190837084929: 5mm Calcaneal Step Plate
• 00190837084912: 4mm Calcaneal Step Plate
• 00190837084905: 10mm Calcaneal Step Plate
• 00190837084899: 9mm Calcaneal Step Plate
• 00190837084882: 8mm Calcaneal Step Plate
• 00190837084875: 7mm Calcaneal Step Plate
• 00190837084868: 6mm Calcaneal Step Plate
• 00190837084851: 5mm Calcaneal Step Plate
• 00190837084844: 4mm Calcaneal Step Plate
• 00190837084837: Contoured T Compression Plate, 30mm
• 00190837084820: Contoured T Compression Plate, 20mm
• 00190837084813: Contoured T Compression Plate, 30mm
• 00190837084806: Contoured T Compression Plate, 20mm
• 00190837084790: Contoured T Plate, 30mm
• 00190837084783: Contoured T Plate, 30mm
• 00190837084776: Contoured T Plate, 10mm
• 00190837084769: Contoured T Plate, 30mm
• 00190837084752: Contoured T Plate, 30mm
• 00190837084745: Contoured T Plate, 10mm
• 00190837084738: T Compression Plate, 30mm
• 00190837084721: T Compression Plate, 20mm
• 00190837084714: T Compression Plate, 30mm
• 00190837084707: T Compression Plate, 20mm
• 00190837084691: T Plate, 30mm
• 00190837084684: T Plate, 20mm
• 00190837084677: T Plate, 10mm
• 00190837084660: T Plate, 30mm
• 00190837084653: T Plate, 20mm
• 00190837084646: T Plate, 10mm
• 00190837084639: Straight Compression Plate, 30mm
• 00190837084622: Straight Compression Plate, 20mm
• 00190837084615: Straight Compression Plate, 30mm
• 00190837084608: Straight Compression Plate, 20mm
• 00190837084592: Straight Plate, 30mm
• 00190837084585: Straight Plate, 20mm
• 00190837084578: Straight Plate, 10mm
• 00190837084561: Straight Plate, 30mm
• 00190837084554: Straight Plate, 20mm
• 00190837084547: Straight Plate, 10mm
• 00190837084530: 28mm Right Lapidus Compression Plate, 6mm Step
• 00190837084523: 28mm Left Lapidus Compression Plate, 6mm Step
• 00190837084516: 28mm Right Lapidus Compression Plate, 5mm Step
• 00190837084509: 28mm Left Lapidus Compression Plate, 5mm Step
• 00190837084493: 28mm Right Lapidus Compression Plate, 4mm Step
• 00190837084486: 28mm Left Lapidus Compression Plate, 4mm Step