Smart Correction 11-707-650250S

GUDID B56211707650250S0

6.0/250/50mm Half Pin, Self-Drilling/Self-Tapping, QC, SS, HA+

Wishbone Medical, Inc.

External orthopaedic fixation system, single-use

• Primary Device ID: B56211707650250S0
• NIH Device Record Key: 9aeff689-f265-4990-b951-34187c6396b8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Smart Correction
• Version Model Number: 11-707-650250S
• Catalog Number: 11-707-650250S
• Company DUNS: 062355158
• Company Name: Wishbone Medical, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	B56211707650250S0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231461

FDA Product Code

• KTT: Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-03
• Device Publish Date: 2023-06-23

On-Brand Devices [Smart Correction]

• B562SCSTRUTCASENSE0: Smart Correction Strut Case
• B562SCS0000: Smart Correction Loaner Set
• B562SCRINGCASE2NSE0: Smart Correction Two Third and Foot Ring Case
• B562SCRINGCASE1NSE0: Smart Correction Full Ring Case
• B562SCPINCASENSE0: Smart Correction Pins and Wires Case
• B562SCINSTCASE2NSE0: Smart Correction Instruments Case 2
• B562SCINSTCASE1NSE0: Smart Correction Instruments Case 1
• B562SCCLAMPCASENSE0: Smart Correction Clamps and Bolts Case
• B562C2C20210: Click2Correct/ Smart Correction software
• B5625060PC06NS0: Half Pin Covers, 6mm (6 pack) - Non-Sterile
• B562501860255SWBNS0: Half Pin, 6.0/250/50mm, Self Drilling, QC, SS - Non-Sterile
• B562501860254SWBNS0: Half Pin, 6.0/250/40mm, Self Drilling, QC, SS - Non-Sterile
• B562501860254BLWBNS0: Half Pin, 6.0/250/40mm, Blunt Self Tapping, QC, SS - Non-Sterile
• B562501860253SWBNS0: Half Pin, 6.0/250/30mm, Self Drilling, QC, SS - Non-Sterile
• B562501860253BLWBNS0: Half Pin, 6.0/250/30mm, Blunt Self Tapping, QC, SS - Non-Sterile
• B562501860225SWBNS0: Half Pin, 6.0/220/50mm, Self Drilling, QC, SS - Non-Sterile
• B562501860224SWBNS0: Half Pin, 6.0/220/40mm, Self Drilling, QC, SS - Non-Sterile
• B562501860224BLWBNS0: Half Pin, 6.0/220/40mm, Blunt Self Tapping, QC, SS - Non-Sterile
• B562501860223SWBNS0: Half Pin, 6.0/220/30mm, Self Drilling, QC, SS - Non-Sterile
• B562501860223BLWBNS0: Half Pin, 6.0/220/30mm, Blunt Self Tapping, QC, SS - Non-Sterile
• B562501860205SWBNS0: Half Pin, 6.0/200/50mm, Self Drilling, QC, SS - Non-Sterile
• B562501860205BLWBNS0: Half Pin, 6.0/200/50mm, Blunt Self Tapping, QC, SS - Non-Sterile
• B562501860204SWBNS0: Half Pin, 6.0/200/40mm, Self Drilling, QC, SS - Non-Sterile
• B562501860204BLWBNS0: Half Pin, 6.0/200/40mm, Blunt Self Tapping, QC, SS - Non-Sterile
• B562501860203SWBNS0: Half Pin, 6.0/200/30mm, Self Drilling, QC, SS - Non-Sterile
• B562501860203BLWBNS0: Half Pin, 6.0/200/30mm, Blunt Self Tapping, QC, SS - Non-Sterile
• B562501860184SWBNS0: Half Pin, 6.0/180/40mm, Self Drilling, QC, SS - Non-Sterile
• B562501860184BLWBNS0: Half Pin, 6.0/180/40mm, Blunt Self Tapping, QC, SS - Non-Sterile
• B562501860183SWBNS0: Half Pin, 6.0/180/30mm, Self Drilling, QC, SS - Non-Sterile
• B562501860183BLWBNS0: Half Pin, 6.0/180/30mm, Blunt Self Tapping, QC, SS - Non-Sterile
• B562501860154SWBNS0: Half Pin, 6.0/150/40mm, Self Drilling, QC, SS - Non-Sterile
• B562501860154BLWBNS0: Half Pin, 6.0/150/40mm, Blunt Self Tapping, QC, SS - Non-Sterile
• B562501860153SWBNS0: Half Pin, 6.0/150/30mm, Self Drilling, QC, SS - Non-Sterile
• B562501860153BLWBNS0: Half Pin, 6.0/150/30mm, Blunt Self Tapping, QC, SS - Non-Sterile
• B562501850255SWBNS0: Half Pin, 5.0/250/50mm, Self Drilling, QC, SS - Non-Sterile
• B562501850255BLWBNS0: Half Pin, 5.0/250/50mm, Blunt Self Tapping, QC, SS - Non-Sterile
• B562501850254SWBNS0: Half Pin, 5.0/250/40mm, Self Drilling, QC, SS - Non-Sterile
• B562501850254BLWBNS0: Half Pin, 5.0/250/40mm, Blunt Self Tapping, QC, SS - Non-Sterile
• B562501850253SWBNS0: Half Pin, 5.0/250/30mm, Self Drilling, QC, SS - Non-Sterile
• B562501850253BLWBNS0: Half Pin, 5.0/250/30mm, Blunt Self Tapping, QC, SS - Non-Sterile
• B562501850225SWBNS0: Half Pin, 5.0/220/50mm, Self Drilling, QC, SS - Non-Sterile
• B562501850225BLWBNS0: Half Pin, 5.0/220/50mm, Blunt Self Tapping, QC, SS - Non-Sterile
• B562501850224SWBNS0: Half Pin, 5.0/220/40mm, Self Drilling, QC, SS - Non-Sterile
• B562501850224BLWBNS0: Half Pin, 5.0/220/40mm, Blunt Self Tapping, QC, SS - Non-Sterile
• B562501850223SWBNS0: Half Pin, 5.0/220/30mm, Self Drilling, QC, SS - Non-Sterile
• B562501850223BLWBNS0: Half Pin, 5.0/220/30mm, Blunt Self Tapping, QC, SS - Non-Sterile
• B562501850205SWBNS0: Half Pin, 5.0/200/50mm, Self Drilling, QC, SS - Non-Sterile
• B562501850205BLWBNS0: Half Pin, 5.0/200/50mm, Blunt Self Tapping, QC, SS - Non-Sterile
• B562501850204SWBNS0: Half Pin, 5.0/200/40mm, Self Drilling, QC, SS - Non-Sterile
• B562501850204BLWBNS0: Half Pin, 5.0/200/40mm, Blunt Self Tapping, QC, SS - Non-Sterile