MC+ MC960R

GUDID 03662663044332

LDR Spine Usa, Inc.

Orthopaedic implant impactor Orthopaedic implant impactor Orthopaedic implant impactor Orthopaedic implant impactor Orthopaedic implant impactor Orthopaedic implant impactor Orthopaedic implant impactor Orthopaedic implant impactor Orthopaedic implant impactor Orthopaedic implant impactor Orthopaedic implant impactor Orthopaedic implant impactor Orthopaedic implant impactor Orthopaedic implant impactor Orthopaedic implant impactor Orthopaedic implant impactor Orthopaedic implant impactor Orthopaedic implant impactor Orthopaedic implant impactor Orthopaedic implant impactor Orthopaedic implant impactor Orthopaedic implant impactor Orthopaedic implant impactor Orthopaedic implant impactor Orthopaedic implant impactor Orthopaedic implant impactor Orthopaedic implant impactor Orthopaedic implant impactor Orthopaedic implant impactor Orthopaedic implant impactor Orthopaedic implant impactor

• Primary Device ID: 03662663044332
• NIH Device Record Key: c800a57a-61f8-4ce1-8970-b613ddad720a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MC+
• Version Model Number: MC960R
• Catalog Number: MC960R
• Company DUNS: 615789729
• Company Name: LDR Spine Usa, Inc.
• 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: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	03662663044332 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121103

FDA Product Code

• NKB: Thoracolumbosacral Pedicle Screw System

Sterilization

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

[03662663044332]

Moist Heat or Steam Sterilization

[03662663044332]

Moist Heat or Steam Sterilization

[03662663044332]

Moist Heat or Steam Sterilization

[03662663044332]

Moist Heat or Steam Sterilization

[03662663044332]

Moist Heat or Steam Sterilization

[03662663044332]

Moist Heat or Steam Sterilization

[03662663044332]

Moist Heat or Steam Sterilization

[03662663044332]

Moist Heat or Steam Sterilization

[03662663044332]

Moist Heat or Steam Sterilization

[03662663044332]

Moist Heat or Steam Sterilization

[03662663044332]

Moist Heat or Steam Sterilization

[03662663044332]

Moist Heat or Steam Sterilization

[03662663044332]

Moist Heat or Steam Sterilization

[03662663044332]

Moist Heat or Steam Sterilization

[03662663044332]

Moist Heat or Steam Sterilization

[03662663044332]

Moist Heat or Steam Sterilization

[03662663044332]

Moist Heat or Steam Sterilization

[03662663044332]

Moist Heat or Steam Sterilization

[03662663044332]

Moist Heat or Steam Sterilization

[03662663044332]

Moist Heat or Steam Sterilization

[03662663044332]

Moist Heat or Steam Sterilization

[03662663044332]

Moist Heat or Steam Sterilization

[03662663044332]

Moist Heat or Steam Sterilization

[03662663044332]

Moist Heat or Steam Sterilization

[03662663044332]

Moist Heat or Steam Sterilization

[03662663044332]

Moist Heat or Steam Sterilization

[03662663044332]

Moist Heat or Steam Sterilization

[03662663044332]

Moist Heat or Steam Sterilization

[03662663044332]

Moist Heat or Steam Sterilization

[03662663044332]

Moist Heat or Steam Sterilization

[03662663044332]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2022-03-10
• Device Publish Date: 2018-12-11

On-Brand Devices [MC+]

• 03662663022132: MC+ CLOSED V.B.R. 12x15.5H7MM
• 03662663022125: MC+ CLOSED V.B.R. 12x15.5H6MM
• 03662663022118: MC+ CLOSED V.B.R. 12x15. 5H5 MM
• 03662663022101: MC+ CLOSED V.B.R. 12x15. 5H4,5 MM
• 03662663022064: MC+ CLOSED V.B.R.12X14 H7 MM
• 03662663022057: MC+ CLOSED V.B.R.12X14 H6 MM
• 03662663022040: MC+ CLOSED V.B.R. 12X14 H5 MM
• 03662663022033: MC+ CLOSED V.B.R. 12X14 H4.5 MM
• 03662663021999: MC+ CLOSED V.B.R.14x17 H7 MM
• 03662663021982: MC+ CLOSED V.B.R. 14x17 H6 MM
• 03662663021975: MC+ CLOSED V.B.R. 14x17 H5 MM
• 03662663021937: MC+ CLOSED V.B.R.14x15.5 H7 MM
• 03662663021920: MC+ CLOSED V.B.R.14x15.5 H6 MM
• 03662663021913: MC+ CLOSED V.B.R.14x15.5 H5 MM
• 03662663021906: MC+ CLOSED V.B.R.14x15.5 H4.5 MM
• 03662663021869: MC+ CLOSED V.B.R. 14x14 H7 MM
• 03662663021852: MC+ CLOSED V.B.R.14x14 H6 MM
• 03662663021845: MC+ CLOSED V.B.R.14x14 H5 MM
• 03662663021838: MC+ CLOSED V.B.R.14X14 H4.5 MM
• 03662663021821: MC+ OPEN V.B.R.12X15.5H7MM
• 03662663021814: MC+ OPEN V.B.R.12X15.5H6MM
• 03662663021807: MC+ OPEN V.B.R.12X15.5H5MM
• 03662663021760: MC+ OPEN V.B.R.14x17 H7 MM
• 03662663021753: MC+ OPEN V.B.R.14x17 H6 MM
• 03662663021746: MC+ OPEN V.B.R.14x17 H5 MM
• 03662663021739: MC+ OPEN V.B.R.14x15.5 H7MM
• 03662663021722: MC+ OPEN V.B.R.14x15.5 H6 MM
• 03662663021708: MC+ OPEN V.B.R.14X14 H7 MM
• 03662663021692: MC+ OPEN V.B.R.14X14 H6 MM
• 03662663021685: MC+ OPEN V.B.R.14X14 H5 MM
• 03662663044158: MC936R
• 03662663043687: MC909R
• 03662663043304: MC901R
• 03662663046077: MC990
• 03662663045506: MC928R
• 03662663045490: MC906R
• 03662663044332: MC960R
• 03662663044325: TRIAL CERVICAL IMPLANT 12X15.5 H10 MM
• 03662663044318: TRIAL CERVICAL IMPLANT 12X15.5 H9 MM
• 03662663044301: TRIAL CERVICAL IMPLANT 12X15.5 H8 MM
• 03662663044295: TRIAL CERVICAL IMPLANT 12X14 H10 MM
• 03662663044288: TRIAL CERVICAL IMPLANT 12X14 H9 MM
• 03662663044271: TRIAL CERVICAL IMPLANT 12X14 H8 MM
• 03662663044264: TRIAL CERVICAL IMPLANT 14X17 H10 MM
• 03662663044257: TRIAL CERVICAL IMPLANT 14X17 H9 MM
• 03662663044240: TRIAL CERVICAL IMPLANT 14X17 H8 MM
• 03662663044233: TRIAL CERVICAL IMPLANT 14X15.5 H10 MM
• 03662663044226: TRIAL CERVICAL IMPLANT 14X15.5 H9 MM
• 03662663044219: TRIAL CERVICAL IMPLANT 14X15.5 H8 MM
• 03662663044202: TRIAL CERVICAL IMPLANT 14X14 H10 MM