Cervical Interbody Fusion Device CR1517-06

GUDID B565CR1517061

Cervical RASP 6 mm

Maxim Surgical

Bone file/rasp, manual

• Primary Device ID: B565CR1517061
• NIH Device Record Key: 303b592f-c4bd-45d9-860f-5c7f13cbc320
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cervical Interbody Fusion Device
• Version Model Number: CR1517-06
• Catalog Number: CR1517-06
• Company DUNS: 012241561
• Company Name: Maxim Surgical
• 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: 9723315860
• Email: xx@xx.xx
• Phone: 9723315860
• Email: xx@xx.xx
• Phone: 9723315860
• Email: xx@xx.xx
• Phone: 9723315860
• Email: xx@xx.xx
• Phone: 9723315860
• Email: xx@xx.xx
• Phone: 9723315860
• Email: xx@xx.xx
• Phone: 9723315860
• Email: xx@xx.xx
• Phone: 9723315860
• Email: xx@xx.xx

Device Dimensions

• Height: 6 Millimeter
• Height: 6 Millimeter
• Height: 6 Millimeter
• Height: 6 Millimeter
• Height: 6 Millimeter
• Height: 6 Millimeter
• Height: 6 Millimeter
• Height: 6 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B565CR1517061 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123206

FDA Product Code

• ODP: Intervertebral Fusion Device With Bone Graft, Cervical

Sterilization

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

[B565CR1517061]

Moist Heat or Steam Sterilization

[B565CR1517061]

Moist Heat or Steam Sterilization

[B565CR1517061]

Moist Heat or Steam Sterilization

[B565CR1517061]

Moist Heat or Steam Sterilization

[B565CR1517061]

Moist Heat or Steam Sterilization

[B565CR1517061]

Moist Heat or Steam Sterilization

[B565CR1517061]

Moist Heat or Steam Sterilization

[B565CR1517061]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-12-07
• Device Publish Date: 2017-07-21

On-Brand Devices [Cervical Interbody Fusion Device]

• B565MF2004C011: Sterilization Tray
• B565FP20011: Final Positioner
• B565CT17101: Cervical Trial 17x10 mm w/Stop
• B565CT171001: Cervical Trial 17x10 mm No Stop
• B565CT17091: Cervical Trial 17x9 mm w/Stop
• B565CT170901: Cervical Trial 17x9 mm No Stop
• B565CT17081: Cervical Trial 17x8 mm w/Stop
• B565CT170801: Cervical Trial 17x8 mm No Stop
• B565CT17071: Cervical Trial 17x7 mm w/Stop
• B565CT170701: Cervical Trial 17x7 mm No Stop
• B565CT17061: Cervical Trial 17x6 mm w/Stop
• B565CT170601: Cervical Trial 17x6 mm No Stop
• B565CT170501: Cervical Trial 17x5 mm No Stop
• B565CT15101: Cervical Trial 15x10 mm w/Stop
• B565CT151001: Cervical Trial 15x10 mm No Stop
• B565CT15091: Cervical Trial 15x9 mm w/Stop
• B565CT150901: Cervical Trial 15x9 mm No Stop
• B565CT15081: Cervical Trial 15x8 mm w/Stop
• B565CT150801: Cervical Trial 15x8 mm No Stop
• B565CT15071: Cervical Trial 15x7 mm w/Stop
• B565CT150701: Cervical Trial 15x7 mm No Stop
• B565CT15061: Cervical Trial 15x6 mm w/Stop
• B565CT150601: Cervical Trial 15x6 mm No Stop
• B565CT150501: Cervical Trial 15x5 mm No Stop
• B565CR1517101: Cervical RASP 10 mm
• B565CR1517091: Cervical RASP 9 mm
• B565CR1517081: Cervical RASP 8 mm
• B565CR1517071: Cervical RASP 7 mm
• B565CR1517061: Cervical RASP 6 mm
• B565CR1517051: Cervical RASP 5 mm
• B565CI10011: Implant Inserter
• B5651790400021: Caddy Tray Large Implants
• B5651790400011: Caddy Tray Small Implants
• B5651710N1: PEEK Cervical Spacer 17x14x10 mm Neutral
• B5651710L1: PEEK Cervical Spacer 17x14x10 mm Lordotic 6 degrees
• B5651709N1: PEEK Cervical Spacer 17x14x9 mm Neutral
• B5651709L1: PEEK Cervical Spacer 17x14x9 mm Lordotic 6 degrees
• B5651708N1: PEEK Cervical Spacer 17x14x8 mm Neutral
• B5651708L1: PEEK Cervical Spacer 17x14x8 mm Lordotic 6 degrees
• B5651707N1: PEEK Cervical Spacer 17x14x7 mm Neutral
• B5651707L1: PEEK Cervical Spacer 17x14x7 mm Lordotic 6 degrees
• B5651706N1: PEEK Cervical Spacer 17x14x6 mm Neutral
• B5651706L1: PEEK Cervical Spacer 17x14x6 mm Lordotic 6 degrees
• B5651510N1: PEEK Cervical Spacer 15x13x10 mm Neutral
• B5651510L1: PEEK Cervical Spacer 15x13x10 mm Lordotic 6 degrees
• B5651509N1: PEEK Cervical Spacer 15x13x9 mm Neutral
• B5651509L1: PEEK Cervical Spacer 15x13x9 mm Lordotic 6 degrees
• B5651508N1: PEEK Cervical Spacer 15x13x8 mm Neutral
• B5651508L1: PEEK Cervical Spacer 15x13x8 mm Lordotic 6 degrees
• B5651507N1: PEEK Cervical Spacer 15x13x7 mm Neutral