Double Implant Positioner

GUDID 00853190008567

JACE MEDICAL, LLC

Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial

• Primary Device ID: 00853190008567
• NIH Device Record Key: 2241943c-d6ad-481c-a543-87f7fb2f612f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Double Implant Positioner
• Version Model Number: 215.010.12
• Company DUNS: 063554875
• Company Name: JACE MEDICAL, LLC
• 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: 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853190008567 [Primary]

FDA Product Code

• PBF: Orthopaedic Surgical Planning And Instrument Guides

Sterilization

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

[00853190008567]

Moist Heat or Steam Sterilization

[00853190008567]

Moist Heat or Steam Sterilization

[00853190008567]

Moist Heat or Steam Sterilization

[00853190008567]

Moist Heat or Steam Sterilization

[00853190008567]

Moist Heat or Steam Sterilization

[00853190008567]

Moist Heat or Steam Sterilization

[00853190008567]

Moist Heat or Steam Sterilization

[00853190008567]

Moist Heat or Steam Sterilization

[00853190008567]

Moist Heat or Steam Sterilization

[00853190008567]

Moist Heat or Steam Sterilization

[00853190008567]

Moist Heat or Steam Sterilization

[00853190008567]

Moist Heat or Steam Sterilization

[00853190008567]

Moist Heat or Steam Sterilization

[00853190008567]

Moist Heat or Steam Sterilization

[00853190008567]

Moist Heat or Steam Sterilization

[00853190008567]

Moist Heat or Steam Sterilization

[00853190008567]

Moist Heat or Steam Sterilization

[00853190008567]

Moist Heat or Steam Sterilization

[00853190008567]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-02-07
• Device Publish Date: 2018-05-16

Devices Manufactured by JACE MEDICAL, LLC

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• 00850051329014 - Sternalock EZ: 2023-11-28 Y Plate, 12 Holes, Narrow
• 00850051329021 - Sternalock EZ: 2023-11-28 Y Plate, 12 Holes, Wide
• 00853190008352 - Sternalock EZ: 2023-11-28 V Plate, 8 Holes
• 00853190008512 - Sternalock EZ: 2023-11-28 V Plate, 4 Holes
• 00853190008529 - Sternalock EZ: 2023-11-28 H Plate, 6 Holes
• 00853190008635 - Sternalock EZ: 2023-11-28 Box Plate, 4 Holes
• 00853190008642 - Sternalock EZ: 2023-11-28 O Plate, 6 Hole