MIS Polyaxial Pedicle Screw

GUDID B030CM008010

Ø5.5mm mis straight rod ,150mm Lg.

CAMBER SPINE TECHNOLOGIES, LLC

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: B030CM008010
• NIH Device Record Key: ec8db0fa-ca4a-4b36-97d4-19f57b6eda31
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MIS Polyaxial Pedicle Screw
• Version Model Number: CM-008-01
• Company DUNS: 054205979
• Company Name: CAMBER SPINE TECHNOLOGIES, 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

Customer Support Contacts

• Phone: 1-866-643-0739
• Email: customerservice@cambermedtech.com
• Phone: 1-866-643-0739
• Email: customerservice@cambermedtech.com
• Phone: 1-866-643-0739
• Email: customerservice@cambermedtech.com
• Phone: 1-866-643-0739
• Email: customerservice@cambermedtech.com
• Phone: 1-866-643-0739
• Email: customerservice@cambermedtech.com
• Phone: 1-866-643-0739
• Email: customerservice@cambermedtech.com
• Phone: 1-866-643-0739
• Email: customerservice@cambermedtech.com
• Phone: 1-866-643-0739
• Email: customerservice@cambermedtech.com
• Phone: 1-866-643-0739
• Email: customerservice@cambermedtech.com
• Phone: 1-866-643-0739
• Email: customerservice@cambermedtech.com
• Phone: 1-866-643-0739
• Email: customerservice@cambermedtech.com
• Phone: 1-866-643-0739
• Email: customerservice@cambermedtech.com
• Phone: 1-866-643-0739
• Email: customerservice@cambermedtech.com
• Phone: 1-866-643-0739
• Email: customerservice@cambermedtech.com
• Phone: 1-866-643-0739
• Email: customerservice@cambermedtech.com
• Phone: 1-866-643-0739
• Email: customerservice@cambermedtech.com
• Phone: 1-866-643-0739
• Email: customerservice@cambermedtech.com
• Phone: 1-866-643-0739
• Email: customerservice@cambermedtech.com
• Phone: 1-866-643-0739
• Email: customerservice@cambermedtech.com
• Phone: 1-866-643-0739
• Email: customerservice@cambermedtech.com
• Phone: 1-866-643-0739
• Email: customerservice@cambermedtech.com
• Phone: 1-866-643-0739
• Email: customerservice@cambermedtech.com
• Phone: 1-866-643-0739
• Email: customerservice@cambermedtech.com
• Phone: 1-866-643-0739
• Email: customerservice@cambermedtech.com
• Phone: 1-866-643-0739
• Email: customerservice@cambermedtech.com
• Phone: 1-866-643-0739
• Email: customerservice@cambermedtech.com
• Phone: 1-866-643-0739
• Email: customerservice@cambermedtech.com
• Phone: 1-866-643-0739
• Email: customerservice@cambermedtech.com
• Phone: 1-866-643-0739
• Email: customerservice@cambermedtech.com
• Phone: 1-866-643-0739
• Email: customerservice@cambermedtech.com
• Phone: 1-866-643-0739
• Email: customerservice@cambermedtech.com
• Phone: 1-866-643-0739
• Email: customerservice@cambermedtech.com
• Phone: 1-866-643-0739
• Email: customerservice@cambermedtech.com
• Phone: 1-866-643-0739
• Email: customerservice@cambermedtech.com
• Phone: 1-866-643-0739
• Email: customerservice@cambermedtech.com

Device Dimensions

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Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B030CM008010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133366

FDA Product Code

• NKB: Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease

Sterilization

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

[B030CM008010]

Moist Heat or Steam Sterilization

[B030CM008010]

Moist Heat or Steam Sterilization

[B030CM008010]

Moist Heat or Steam Sterilization

[B030CM008010]

Moist Heat or Steam Sterilization

[B030CM008010]

Moist Heat or Steam Sterilization

[B030CM008010]

Moist Heat or Steam Sterilization

[B030CM008010]

Moist Heat or Steam Sterilization

[B030CM008010]

Moist Heat or Steam Sterilization

[B030CM008010]

Moist Heat or Steam Sterilization

[B030CM008010]

Moist Heat or Steam Sterilization

[B030CM008010]

Moist Heat or Steam Sterilization

[B030CM008010]

Moist Heat or Steam Sterilization

[B030CM008010]

Moist Heat or Steam Sterilization

[B030CM008010]

Moist Heat or Steam Sterilization

[B030CM008010]

Moist Heat or Steam Sterilization

[B030CM008010]

Moist Heat or Steam Sterilization

[B030CM008010]

Moist Heat or Steam Sterilization

[B030CM008010]

Moist Heat or Steam Sterilization

[B030CM008010]

Moist Heat or Steam Sterilization

[B030CM008010]

Moist Heat or Steam Sterilization

[B030CM008010]

Moist Heat or Steam Sterilization

[B030CM008010]

Moist Heat or Steam Sterilization

[B030CM008010]

Moist Heat or Steam Sterilization

[B030CM008010]

Moist Heat or Steam Sterilization

[B030CM008010]

Moist Heat or Steam Sterilization

[B030CM008010]

Moist Heat or Steam Sterilization

[B030CM008010]

Moist Heat or Steam Sterilization

[B030CM008010]

Moist Heat or Steam Sterilization

[B030CM008010]

Moist Heat or Steam Sterilization

[B030CM008010]

Moist Heat or Steam Sterilization

[B030CM008010]

Moist Heat or Steam Sterilization

[B030CM008010]

Moist Heat or Steam Sterilization

[B030CM008010]

Moist Heat or Steam Sterilization

[B030CM008010]

Moist Heat or Steam Sterilization

[B030CM008010]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-02-05
• Device Publish Date: 2016-10-19

On-Brand Devices [MIS Polyaxial Pedicle Screw]

• B030CM134050: Ø5.0mm mis cannulated tap,1/4"QC
• B030CM134040: Ø8.5mm mis cannulated tap,1/4"QC
• B030CM134030: Ø7.5mm mis cannulated tap,1/4"QC
• B030CM134020: Ø6.5mm mis cannulated tap,1/4"QC
• B030CM134010: Ø5.5mm mis cannulated tap,1/4"QC
• B030CM130050: Ø1.6mm K-Wire, threaded Tip
• B030CM130040: Ø1.6mm K-Wire, trocar Tip
• B030CM130030: Ø1.6mm K-Wire, blunt Tip
• B030CM130020: Ø1.6mm K-Wire, trocar Tip
• B030CM130010: Ø1.6mm K-Wire, Blunt Tip
• B030CM009310: Ø5.5mm mis curved rod , 20mm Lg.
• B030CM009300: Ø5.5mm mis curved rod , 30mm Lg.
• B030CM009280: Ø5.5mm mis curved rod ,180mm Lg. (transition)
• B030CM009270: Ø5.5mm mis curved rod ,160mm Lg. (transition)
• B030CM009260: Ø5.5mm mis curved rod ,180mm Lg.
• B030CM009250: Ø5.5mm mis curved rod ,160mm Lg.
• B030CM009240: Ø5.5mm mis curved rod ,150mm Lg.
• B030CM009230: Ø5.5mm mis curved rod ,145mm Lg.
• B030CM009220: Ø5.5mm mis curved rod ,140mm Lg.
• B030CM009210: Ø5.5mm mis curved rod ,135mm Lg.
• B030CM009200: Ø5.5mm mis curved rod ,130mm Lg.
• B030CM009190: Ø5.5mm mis curved rod ,125mm Lg.
• B030CM009180: Ø5.5mm mis curved rod ,120mm Lg.
• B030CM009170: Ø5.5mm mis curved rod ,115mm Lg.
• B030CM009160: Ø5.5mm mis curved rod ,110mm Lg.
• B030CM009150: Ø5.5mm mis curved rod ,105mm Lg.
• B030CM009140: Ø5.5mm mis curved rod ,100mm Lg.
• B030CM009130: Ø5.5mm mis curved rod ,95mm Lg.
• B030CM009120: Ø5.5mm mis curved rod ,90mm Lg.
• B030CM009110: Ø5.5mm mis curved rod ,85mm Lg.
• B030CM009100: Ø5.5mm mis curved rod ,80mm Lg.
• B030CM009090: Ø5.5mm mis curved rod ,75mm Lg.
• B030CM009080: Ø5.5mm mis curved rod ,70mm Lg.
• B030CM009070: Ø5.5mm mis curved rod ,65mm Lg.
• B030CM009060: Ø5.5mm mis curved rod ,60mm Lg.
• B030CM009050: Ø5.5mm mis curved rod ,55mm Lg.
• B030CM009040: Ø5.5mm mis curved rod ,50mm Lg.
• B030CM009030: Ø5.5mm mis curved rod ,45mm Lg.
• B030CM009020: Ø5.5mm mis curved rod ,40mm Lg.
• B030CM009010: Ø5.5mm mis curved rod ,35mm Lg.
• B030CM009000: Ø5.5mm mis curved rod ,25mm Lg.
• B030CM008040: Ø5.5mm mis straight rod ,400mm Lg.
• B030CM008030: Ø5.5mm mis straight rod ,300mm Lg.
• B030CM008020: Ø5.5mm mis straight rod ,200mm Lg.
• B030CM008010: Ø5.5mm mis straight rod ,150mm Lg.
• B030CM006490: Ø8.5mm mis cannulated polyaxial pedicle screw ,110mm Lg.
• B030CM006480: Ø8.5mm mis cannulated polyaxial pedicle screw ,105mm Lg.
• B030CM006470: Ø8.5mm mis cannulated polyaxial pedicle screw ,100mm Lg.
• B030CM006460: Ø8.5mm mis cannulated polyaxial pedicle screw ,95mm Lg.
• B030CM006450: Ø8.5mm mis cannulated polyaxial pedicle screw ,90mm Lg.