SAMBA SCREW SYSTEM

GUDID 11110910

Drill Guide

MEDICAL DESIGNS LLC

Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit

• Primary Device ID: 11110910
• NIH Device Record Key: 03da5766-2a5b-4f40-b6cd-3fcf1d0918d1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SAMBA SCREW SYSTEM
• Version Model Number: 11-1109-FD10
• Company DUNS: 003815548
• Company Name: MEDICAL DESIGNS 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: 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	11110910 [Direct Marking]
HIBCC	M364111109FD100 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121148

FDA Product Code

• OUR: Sacroiliac Joint Fixation

Sterilization

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

[11110910]

Moist Heat or Steam Sterilization

[11110910]

Moist Heat or Steam Sterilization

[11110910]

Moist Heat or Steam Sterilization

[11110910]

Moist Heat or Steam Sterilization

[11110910]

Moist Heat or Steam Sterilization

[11110910]

Moist Heat or Steam Sterilization

[11110910]

Moist Heat or Steam Sterilization

[11110910]

Moist Heat or Steam Sterilization

[11110910]

Moist Heat or Steam Sterilization

[11110910]

Moist Heat or Steam Sterilization

[11110910]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2022-11-28
• Device Publish Date: 2016-09-27

On-Brand Devices [SAMBA SCREW SYSTEM ]

• 11110992: Adjustable Drill Collar
• 11110991: Drill Bit
• 11110982: Packing Tube
• 11110981: Packing Plunger
• 11110973: Parallel Guide Sliding Block
• 11110972: Parallel Guide Locking Nut
• 11110971: Parallel Guide Frame
• M364111109FD211: Long Blunt Steinmann Pin
• M364111109FD201: Short Blunt Steinmann Pin
• 11110919: Sterilization Case
• 11110918: Drill Bit T-Handle
• 11110917: Torx Bit T-Handle
• M364111109FD161: Sharp Steinmann Pin
• 11110915: Plunger Distance Tool
• 11110914: Cannulated Torx Driver Bit
• 11110913: Striker Tube
• 11110911: Pin Sleeve
• 11110910: Drill Guide
• 11110912: Drill Gauge