King Cobra

GUDID B014KCP533

EMINENT SPINE LLC

External spinal fixation system

• Primary Device ID: B014KCP533
• NIH Device Record Key: 806f7a69-38a5-46e1-bdcc-c6ebb3a9ea01
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: King Cobra
• Version Model Number: KCP533
• Company DUNS: 022576742
• Company Name: EMINENT SPINE LLC
• 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: true
• 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
HIBCC	B014KCP533 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103068

FDA Product Code

• KWQ: Appliance, Fixation, Spinal Intervertebral Body

Sterilization

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

[B014KCP533]

Moist Heat or Steam Sterilization

[B014KCP533]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-04-29
• Device Publish Date: 2017-02-09

On-Brand Devices [King Cobra]

• B014KCP864: KCP864
• B014KCP844: KCP844
• B014KCP804: KCP804
• B014KCP764: KCP764
• B014KCP724: KCP724
• B014KCP713: KCP713
• B014KCP683: KCP683
• B014KCP653: KCP653
• B014KCP644: KCP644
• B014KCP623: KCP623
• B014KCP604: KCP604
• B014KCP593: KCP593
• B014KCP563: KCP563
• B014KCP533: KCP533
• B014KCP503: KCP503
• B014KCP482: KCP482
• B014KCP473: KCP473
• B014KCP452: KCP452
• B014KCP4316: KCP4316
• B014KCP4314: KCP4314
• B014KCP4312: KCP4312
• B014KCP422: KCP422
• B014KCP4216: KCP4216
• B014KCP4214: KCP4214
• B014KCP4212: KCP4212
• B014KCP4116: KCP4116
• B014KCP4114: KCP4114
• B014KCP4112: KCP4112
• B014KCP4016: KCP4016
• B014KCP4014: KCP4014
• B014KCP4012: KCP4012
• B014KCP392: KCP392
• B014KCP362: KCP362
• B014KCP332: KCP332
• B014KCP302: KCP302
• B014KCP282: KCP282
• B014KCP281: KCP281
• B014KCP261: KCP261
• B014KCP241: KCP241
• B014KCP221: KCP221
• B014KCP201: KCP201
• B014KCP181: KCP181
• B014KCP161: KCP161
• B014KCP141: KCP141