AccuFit RP System RPIF15-CP

GUDID 00840019912396

AccuFit ALIF RP Cover Plate 15mm

PRECISION SPINE, INC.

Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 00840019912396
• NIH Device Record Key: 6cb46556-7a3f-4eb5-a688-b9e0b374b62c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AccuFit RP System
• Version Model Number: RPIF15-CP
• Catalog Number: RPIF15-CP
• 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: false
• 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	00840019912396 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092193

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

[00840019912396]

Moist Heat or Steam Sterilization

[00840019912396]

Moist Heat or Steam Sterilization

[00840019912396]

Moist Heat or Steam Sterilization

[00840019912396]

Moist Heat or Steam Sterilization

[00840019912396]

Moist Heat or Steam Sterilization

[00840019912396]

Moist Heat or Steam Sterilization

[00840019912396]

Moist Heat or Steam Sterilization

[00840019912396]

Moist Heat or Steam Sterilization

[00840019912396]

Moist Heat or Steam Sterilization

[00840019912396]

Moist Heat or Steam Sterilization

[00840019912396]

Moist Heat or Steam Sterilization

[00840019912396]

Moist Heat or Steam Sterilization

[00840019912396]

Moist Heat or Steam Sterilization

[00840019912396]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-05-09
• Device Publish Date: 2019-05-01

On-Brand Devices [AccuFit RP System]

• 00840019912457: 4.5mm x 35mm SD Screw
• 00840019912440: 4.5mm x 30mm SD Screw
• 00840019912433: 4.5mm x 25mm SD Screw
• 00840019912426: AccuFit ALIF RP Set Screw
• 00840019912419: AccuFit ALIF RP Cover Plate 17mm
• 00840019912402: AccuFit ALIF Recessed Plate IF 17mm
• 00840019912396: AccuFit ALIF RP Cover Plate 15mm
• 00840019912389: AccuFit ALIF Recessed Plate IF 15mm
• 00840019912372: AccuFit ALIF RP Cover Plate 13mm
• 00840019912365: AccuFit ALIF Recessed Plate IF 13mm
• 00840019912358: AccuFit ALIF RP Cover Plate 11mm
• 00840019912341: AccuFit ALIF Recessed Plate IF 11mm
• 00840019912334: AccuFit ALIF RP Cover Plate 9mm
• 00840019912327: AccuFit ALIF Recessed Plate IF 9mm