Smart Correction 31-700-16528RA-1
GUDID B5623170016528RA00
Dual Hole 2/3 Ring, 165mm ID, Aluminum, Red, Non-Sterile
WISHBONE MEDICAL, INC.
External orthopaedic fixation system, single-use| Primary Device ID | B5623170016528RA00 |
| NIH Device Record Key | 3c610e44-25eb-45d3-aa72-094dde9da83b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Smart Correction |
| Version Model Number | 31-700-16528RA-1 |
| Catalog Number | 31-700-16528RA-1 |
| Company DUNS | 062355158 |
| Company Name | WISHBONE MEDICAL, 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 | B5623170016528RA00 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K221366
FDA Product Code
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[B5623170016528RA00]
Moist Heat or Steam Sterilization
[B5623170016528RA00]
Moist Heat or Steam Sterilization
[B5623170016528RA00]
Moist Heat or Steam Sterilization
[B5623170016528RA00]
Moist Heat or Steam Sterilization
[B5623170016528RA00]
Moist Heat or Steam Sterilization
[B5623170016528RA00]
Moist Heat or Steam Sterilization
[B5623170016528RA00]
Moist Heat or Steam Sterilization
[B5623170016528RA00]
Moist Heat or Steam Sterilization
[B5623170016528RA00]
Moist Heat or Steam Sterilization
[B5623170016528RA00]
Moist Heat or Steam Sterilization
[B5623170016528RA00]
Moist Heat or Steam Sterilization
[B5623170016528RA00]
Moist Heat or Steam Sterilization
[B5623170016528RA00]
Moist Heat or Steam Sterilization
[B5623170016528RA00]
Moist Heat or Steam Sterilization
[B5623170016528RA00]
Moist Heat or Steam Sterilization
[B5623170016528RA00]
Moist Heat or Steam Sterilization
[B5623170016528RA00]
Moist Heat or Steam Sterilization
[B5623170016528RA00]
Moist Heat or Steam Sterilization
[B5623170016528RA00]
Moist Heat or Steam Sterilization
[B5623170016528RA00]
Moist Heat or Steam Sterilization
[B5623170016528RA00]
Moist Heat or Steam Sterilization
[B5623170016528RA00]
Moist Heat or Steam Sterilization
[B5623170016528RA00]
Moist Heat or Steam Sterilization
[B5623170016528RA00]
Moist Heat or Steam Sterilization
[B5623170016528RA00]
Moist Heat or Steam Sterilization
[B5623170016528RA00]
Moist Heat or Steam Sterilization
[B5623170016528RA00]
Moist Heat or Steam Sterilization
[B5623170016528RA00]
Moist Heat or Steam Sterilization
[B5623170016528RA00]
Moist Heat or Steam Sterilization
[B5623170016528RA00]
Moist Heat or Steam Sterilization
[B5623170016528RA00]
Moist Heat or Steam Sterilization
[B5623170016528RA00]
Moist Heat or Steam Sterilization
[B5623170016528RA00]
Moist Heat or Steam Sterilization
[B5623170016528RA00]
Moist Heat or Steam Sterilization
[B5623170016528RA00]
Moist Heat or Steam Sterilization
[B5623170016528RA00]
Moist Heat or Steam Sterilization
[B5623170016528RA00]
Moist Heat or Steam Sterilization
[B5623170016528RA00]
Moist Heat or Steam Sterilization
[B5623170016528RA00]
Moist Heat or Steam Sterilization
[B5623170016528RA00]
Moist Heat or Steam Sterilization
[B5623170016528RA00]
Moist Heat or Steam Sterilization
[B5623170016528RA00]
Moist Heat or Steam Sterilization
[B5623170016528RA00]
Moist Heat or Steam Sterilization
[B5623170016528RA00]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-07-26 |
| Device Publish Date | 2022-07-18 |
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 |
Trademark Results [Smart Correction]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SMART CORRECTION 97888972 not registered Live/Pending |
Wishbone Medical, Inc. 2023-04-14 |
 SMART CORRECTION 77666533 3773122 Live/Registered |
RESPONSE ORTHO TEKNOLOJIK URETIM A.S. 2009-02-09 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.