Cambria 93-9206

GUDID 10889981092993

Cambria Trial, Large 15mm x 13mm x 6mm

SEASPINE ORTHOPEDICS CORPORATION

Spinal implant trial

• Primary Device ID: 10889981092993
• NIH Device Record Key: a9d013d7-689e-47f2-a5d8-a89211bc7266
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cambria
• Version Model Number: 93-9206
• Catalog Number: 93-9206
• Company DUNS: 079840876
• Company Name: SEASPINE ORTHOPEDICS CORPORATION
• 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(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com

Device Dimensions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10889981092993 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082309

FDA Product Code

• ODP: Intervertebral fusion device with bone graft, cervical

Sterilization

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

[10889981092993]

Moist Heat or Steam Sterilization

[10889981092993]

Moist Heat or Steam Sterilization

[10889981092993]

Moist Heat or Steam Sterilization

[10889981092993]

Moist Heat or Steam Sterilization

[10889981092993]

Moist Heat or Steam Sterilization

[10889981092993]

Moist Heat or Steam Sterilization

[10889981092993]

Moist Heat or Steam Sterilization

[10889981092993]

Moist Heat or Steam Sterilization

[10889981092993]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-02-07
• Device Publish Date: 2018-04-10

On-Brand Devices [Cambria]

• 10889981129576: Cambria Extended Implant
• 10889981120580: Cambria Rasp, 17 x 13 x 12mm, w/Depth Stop
• 10889981120559: Rasp, 17mm x 12mm x 12mm
• 10889981120542: Cambria Trial, Large 15mm x 13mm x 8mm
• 10889981120528: Large Impactor
• 10889981094140: Cambria Rasp, 17 x 13 x 11mm, w/Depth Stop
• 10889981094133: Cambria Rasp, 17 x 13 x 10mm, w/Depth Stop
• 10889981094126: Cambria Rasp, 17 x 13 x 9mm, w/Depth Stop
• 10889981094119: Cambria Rasp, 17 x 13 x 8mm, w/Depth Stop
• 10889981094102: Cambria Rasp, 17 x 13 x 7mm, w/Depth Stop
• 10889981094096: Cambria Rasp, 17 x 13 x 6mm, w/Depth Stop
• 10889981094089: Cambria Rasp, 17 x 13 x 5mm, w/Depth Stop
• 10889981093785: Cambria Rasp, 13 x 12 x 12mm, w/Depth Stop, Flat
• 10889981093778: Cambria Rasp, 13 x 12 x 11mm, w/Depth Stop, Flat
• 10889981093761: Cambria Rasp, 13 x 12 x 10mm, w/Depth Stop, Flat
• 10889981093754: Cambria Rasp, 13 x 12 x 9mm, w/Depth Stop, Flat
• 10889981093747: Cambria Rasp, 13 x 12 x 8mm, w/Depth Stop, Flat
• 10889981093730: Cambria Rasp, 13 x 12 x 7mm, w/Depth Stop, Flat
• 10889981093723: Cambria Rasp, 13 x 12 x 6mm, w/Depth Stop, Flat
• 10889981093716: Cambria Rasp, 13 x 12 x 5mm, w/Depth Stop, Flat
• 10889981093709: Cambria Rasp, 13 x 12 x 12mm, w/Depth Stop
• 10889981093693: Cambria Rasp, 13 x 12 x 11mm, w/Depth Stop
• 10889981093686: Cambria Rasp, 13 x 12 x 10mm, w/Depth Stop
• 10889981093679: Cambria Rasp, 13 x 12 x 9mm, w/Depth Stop
• 10889981093662: Cambria Rasp, 13 x 12 x 8mm, w/Depth Stop
• 10889981093655: Cambria Rasp, 13 x 12 x 7mm, w/Depth Stop
• 10889981093648: Cambria Rasp, 13 x 12 x 6mm, w/Depth Stop
• 10889981093631: Cambria Rasp, 13 x 12 x 5mm, w/Depth Stop
• 10889981093624: Cambria Rasp, 15 x 13 x 12mm, w/Depth Stop
• 10889981093617: Cambria Rasp, 15 x 13 x 11mm, w/Depth Stop
• 10889981093600: Cambria Rasp, 15 x 13 x 10mm, w/Depth Stop
• 10889981093594: Cambria Rasp, 15 x 13 x 9mm, w/Depth Stop
• 10889981093587: Cambria Rasp, 15 x 13 x 8mm, w/Depth Stop
• 10889981093570: Cambria Rasp, 15 x 13 x 7mm, w/Depth Stop
• 10889981093563: Cambria Rasp, 15 x 13 x 6mm, w/Depth Stop
• 10889981093556: Cambria Rasp, 15 x 13 x 5mm, w/Depth Stop
• 10889981093549: Cambria Rasp, 15 x 13 x 12mm, w/Depth Stop, Flat
• 10889981093532: Cambria Rasp, 15 x 13 x 11mm, w/Depth Stop, Flat
• 10889981093525: Cambria Rasp, 15 x 13 x 10mm, w/Depth Stop, Flat
• 10889981093518: Cambria Rasp, 15 x 13 x 9mm, w/Depth Stop, Flat
• 10889981093501: Cambria Rasp, 15 x 13 x 8mm, w/Depth Stop, Flat
• 10889981093495: Cambria Rasp, 15 x 13 x 7mm, w/Depth Stop, Flat
• 10889981093488: Cambria Rasp, 15 x 13 x 6mm, w/Depth Stop, Flat
• 10889981093471: Cambria Rasp, 15 x 13 x 5mm, w/Depth Stop, Flat
• 10889981093440: Cambria 17mm Implant and Instrument Tray
• 10889981093433: Cambria 17mm Implant Caddy
• 10889981093426: Cambria 15mm Implant Caddy
• 10889981093419: Cambria 13mm Implant Caddy
• 10889981093402: Cambria Instrument & Implant Tray
• 10889981093396: Rasp, 17mm x 12mm x 11mm