48mm ANTERIOR LUMBAR PLATE 25-LP-48

GUDID 00846468028794

48mm ANTERIOR LUMBAR PLATE

Pioneer Surgical Technology, Inc.

Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 00846468028794
• NIH Device Record Key: 75965ad6-7b4e-4154-8241-30e974ed373d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 48mm ANTERIOR LUMBAR PLATE
• Version Model Number: 25-LP-48
• Catalog Number: 25-LP-48
• Company DUNS: 793384496
• Company Name: Pioneer Surgical Technology, 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

Customer Support Contacts

• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00846468028794 [Primary]
GS1	00846468091811 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090222

FDA Product Code

• KWQ: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Sterilization

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

[00846468028794]

Moist Heat or Steam Sterilization

[00846468028794]

Moist Heat or Steam Sterilization

[00846468028794]

Moist Heat or Steam Sterilization

[00846468028794]

Moist Heat or Steam Sterilization

[00846468028794]

Moist Heat or Steam Sterilization

[00846468028794]

Moist Heat or Steam Sterilization

[00846468028794]

Moist Heat or Steam Sterilization

[00846468028794]

Moist Heat or Steam Sterilization

[00846468028794]

Moist Heat or Steam Sterilization

[00846468028794]

Moist Heat or Steam Sterilization

[00846468028794]

Moist Heat or Steam Sterilization

[00846468028794]

Moist Heat or Steam Sterilization

[00846468028794]

Moist Heat or Steam Sterilization

[00846468028794]

Moist Heat or Steam Sterilization

[00846468028794]

Moist Heat or Steam Sterilization

[00846468028794]

Moist Heat or Steam Sterilization

[00846468028794]

Moist Heat or Steam Sterilization

[00846468028794]

Moist Heat or Steam Sterilization

[00846468028794]

Moist Heat or Steam Sterilization

[00846468028794]

Moist Heat or Steam Sterilization

[00846468028794]

Moist Heat or Steam Sterilization

[00846468028794]

Moist Heat or Steam Sterilization

[00846468028794]

Moist Heat or Steam Sterilization

[00846468028794]

Moist Heat or Steam Sterilization

[00846468028794]

Moist Heat or Steam Sterilization

[00846468028794]

Moist Heat or Steam Sterilization

[00846468028794]

Moist Heat or Steam Sterilization

[00846468028794]

Moist Heat or Steam Sterilization

[00846468028794]

Moist Heat or Steam Sterilization

[00846468028794]

Moist Heat or Steam Sterilization

[00846468028794]

Moist Heat or Steam Sterilization

[00846468028794]

Moist Heat or Steam Sterilization

[00846468028794]

Moist Heat or Steam Sterilization

[00846468028794]

Moist Heat or Steam Sterilization

[00846468028794]

Moist Heat or Steam Sterilization

[00846468028794]

Moist Heat or Steam Sterilization

[00846468028794]

Moist Heat or Steam Sterilization

[00846468028794]

Moist Heat or Steam Sterilization

[00846468028794]

Moist Heat or Steam Sterilization

[00846468028794]

Moist Heat or Steam Sterilization

[00846468028794]

Moist Heat or Steam Sterilization

[00846468028794]

Moist Heat or Steam Sterilization

[00846468028794]

Moist Heat or Steam Sterilization

[00846468028794]

Moist Heat or Steam Sterilization

[00846468028794]

Moist Heat or Steam Sterilization

[00846468028794]

Moist Heat or Steam Sterilization

[00846468028794]

Moist Heat or Steam Sterilization

[00846468028794]

Moist Heat or Steam Sterilization

[00846468028794]

Moist Heat or Steam Sterilization

[00846468028794]

Moist Heat or Steam Sterilization

[00846468028794]

Moist Heat or Steam Sterilization

[00846468028794]

Moist Heat or Steam Sterilization

[00846468028794]

Moist Heat or Steam Sterilization

[00846468028794]

Moist Heat or Steam Sterilization

[00846468028794]

Moist Heat or Steam Sterilization

[00846468028794]

Moist Heat or Steam Sterilization

[00846468028794]

Moist Heat or Steam Sterilization

[00846468028794]

Moist Heat or Steam Sterilization

[00846468028794]

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: 2015-11-06

Devices Manufactured by Pioneer Surgical Technology, Inc.

• 00191083033198 - Cross-Fuse® II PEEK IBF System: 2024-04-08 IMPLANT FORK
• 00840298702534 - CODA™ Anterior Cervical Plate System: 2024-02-19 Variable Self Tapping Screw
• 00840298700349 - CODA™ Anterior Cervical Plate System: 2023-12-13 Constrained Self Tapping Screw
• 00840298700356 - CODA™ Anterior Cervical Plate System: 2023-12-13 Constrained Self Tapping Screw
• 00840298700363 - CODA™ Anterior Cervical Plate System: 2023-12-13 Constrained Self Tapping Screw
• 00840298700370 - CODA™ Anterior Cervical Plate System: 2023-12-13 Constrained Self Tapping Screw
• 00840298700387 - CODA™ Anterior Cervical Plate System: 2023-12-13 Constrained Self Tapping Screw
• 00840298700394 - CODA™ Anterior Cervical Plate System: 2023-12-13 Constrained Self Tapping Screw