Manta Ray™ 22-16-4012

GUDID 10889981056827

Screw - Self-Tapping - Variable - 4.0x12mm

SEASPINE ORTHOPEDICS CORPORATION

Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 10889981056827
• NIH Device Record Key: d4d98cc9-3926-44c3-87f5-9da75e9e7f87
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Manta Ray™
• Version Model Number: 22-16-4012
• Catalog Number: 22-16-4012
• 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: 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: 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
• 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 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	10889981056827 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080690

FDA Product Code

• KWQ: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Sterilization

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

[10889981056827]

Moist Heat or Steam Sterilization

[10889981056827]

Moist Heat or Steam Sterilization

[10889981056827]

Moist Heat or Steam Sterilization

[10889981056827]

Moist Heat or Steam Sterilization

[10889981056827]

Moist Heat or Steam Sterilization

[10889981056827]

Moist Heat or Steam Sterilization

[10889981056827]

Moist Heat or Steam Sterilization

[10889981056827]

Moist Heat or Steam Sterilization

[10889981056827]

Moist Heat or Steam Sterilization

[10889981056827]

Moist Heat or Steam Sterilization

[10889981056827]

Moist Heat or Steam Sterilization

[10889981056827]

Moist Heat or Steam Sterilization

[10889981056827]

Moist Heat or Steam Sterilization

[10889981056827]

Moist Heat or Steam Sterilization

[10889981056827]

Moist Heat or Steam Sterilization

[10889981056827]

Moist Heat or Steam Sterilization

[10889981056827]

Moist Heat or Steam Sterilization

[10889981056827]

Moist Heat or Steam Sterilization

[10889981056827]

Moist Heat or Steam Sterilization

[10889981056827]

Moist Heat or Steam Sterilization

[10889981056827]

Moist Heat or Steam Sterilization

[10889981056827]

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: 2015-09-24

On-Brand Devices [Manta Ray™]

• 10889981057589: Screw - Self-Tapping - Variable - 4.5x17mm
• 10889981057572: Screw - Self-Tapping - Variable - 4.5x15mm
• 10889981057565: Screw - Self-Tapping - Variable - 4.5x13mm
• 10889981057558: Screw - Self-Tapping - Variable - 4.0x18 mm
• 10889981057541: Screw - Self-Tapping - Variable - 4.0x17 mm
• 10889981057534: Screw - Self-Tapping - Variable - 4.0x16mm
• 10889981057527: Screw - Self-Tapping - Variable - 4.0x15 mm
• 10889981057510: Screw - Self-Tapping - Variable - 4.0x14mm
• 10889981057503: Screw - Self-Tapping - Variable - 4.0x13 mm
• 10889981057497: Screw - Self-Tapping - Variable - 4.0x12 mm
• 10889981057480: Screw - Self-Tapping - Variable - 4.0x11 mm
• 10889981057473: Screw - Self-Tapping - Variable - 4.0x10mm
• 10889981057466: Screw - Self-Drilling - Variable - 4.5x19mm
• 10889981057459: Screw - Self-Drilling - Variable - 4.5x17mm
• 10889981057442: Screw - Self-Drilling - Variable - 4.5x15mm
• 10889981057435: Screw - Self-Drilling - Variable - 4.5x13mm
• 10889981057428: Screw - Self-Drilling - Variable - 4.5x11mm
• 10889981057411: Screw - Self-Drilling - Variable - 4.0x18mm
• 10889981057404: Screw - Self-Drilling - Variable - 4.0x17mm
• 10889981057398: Screw - Self-Drilling - Variable - 4.0x16mm
• 10889981057381: Screw - Self-Drilling - Variable - 4.0x15mm
• 10889981057374: Screw - Self-Drilling - Variable - 4.0x14mm
• 10889981057367: Screw - Self-Drilling - Variable - 4.0x13mm
• 10889981057350: Screw - Self-Drilling - Variable - 4.0x12mm
• 10889981057343: Screw - Self-Drilling - Variable - 4.0x11mm
• 10889981057336: Screw - Self-Drilling - Variable - 4.0x10mm
• 10889981057329: Plate - 4 Level - 92 mm
• 10889981057312: Plate - 4 Level - 88 mm
• 10889981057305: Plate - 4 Level - 84 mm
• 10889981057299: Plate - 4 Level - 80 mm
• 10889981057282: Plate - 4 Level - 76 mm
• 10889981057275: Plate - 4 Level - 72 mm
• 10889981057268: Plate - 4 Level - 68 mm
• 10889981057251: Plate - 3 Level - 75 mm
• 10889981057244: Plate - 3 Level - 72 mm
• 10889981057237: Plate - 3 Level - 69 mm
• 10889981057220: Plate - 3 Level - 66 mm
• 10889981057213: Plate - 3 Level - 63 mm
• 10889981057206: Plate - 3 Level - 60 mm
• 10889981057190: Plate - 3 Level - 57 mm
• 10889981057183: Plate - 3 Level - 54 mm
• 10889981057176: Plate - 3 Level - 51 mm
• 10889981057169: Plate - 3 Level - 48 mm
• 10889981057152: Plate - 2 Level - 52 mm
• 10889981057145: Plate - 2 Level - 49 mm
• 10889981057138: Plate - 2 Level - 46 mm
• 10889981057121: Plate - 2 Level - 43 mm
• 10889981057114: Plate - 2 Level - 40 mm
• 10889981057107: Plate - 2 Level - 37 mm
• 10889981057091: Plate - 2 Level - 34 mm