Smart Correction 50-1850-203BL-WB

GUDID B562501850203BLWB0

Half Pin, 5.0/200/30mm, Blunt Self Tapping, QC, SS, Non-Sterile

WISHBONE MEDICAL, INC.

External orthopaedic fixation system, single-use
Primary Device IDB562501850203BLWB0
NIH Device Record Key1b686f5d-2bbb-4a5e-9f46-df51797f60ff
Commercial Distribution StatusIn Commercial Distribution
Brand NameSmart Correction
Version Model Number50-1850-203BL-WB
Catalog Number50-1850-203BL-WB
Company DUNS062355158
Company NameWISHBONE MEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(574) 306-4006
EmailCustomerService@wishbonemedical.com
Phone(574) 306-4006
EmailCustomerService@wishbonemedical.com
Phone(574) 306-4006
EmailCustomerService@wishbonemedical.com
Phone(574) 306-4006
EmailCustomerService@wishbonemedical.com
Phone(574) 306-4006
EmailCustomerService@wishbonemedical.com
Phone(574) 306-4006
EmailCustomerService@wishbonemedical.com
Phone(574) 306-4006
EmailCustomerService@wishbonemedical.com
Phone(574) 306-4006
EmailCustomerService@wishbonemedical.com
Phone(574) 306-4006
EmailCustomerService@wishbonemedical.com
Phone(574) 306-4006
EmailCustomerService@wishbonemedical.com
Phone(574) 306-4006
EmailCustomerService@wishbonemedical.com
Phone(574) 306-4006
EmailCustomerService@wishbonemedical.com
Phone(574) 306-4006
EmailCustomerService@wishbonemedical.com
Phone(574) 306-4006
EmailCustomerService@wishbonemedical.com
Phone(574) 306-4006
EmailCustomerService@wishbonemedical.com
Phone(574) 306-4006
EmailCustomerService@wishbonemedical.com
Phone(574) 306-4006
EmailCustomerService@wishbonemedical.com
Phone(574) 306-4006
EmailCustomerService@wishbonemedical.com
Phone(574) 306-4006
EmailCustomerService@wishbonemedical.com
Phone(574) 306-4006
EmailCustomerService@wishbonemedical.com
Phone(574) 306-4006
EmailCustomerService@wishbonemedical.com
Phone(574) 306-4006
EmailCustomerService@wishbonemedical.com
Phone(574) 306-4006
EmailCustomerService@wishbonemedical.com
Phone(574) 306-4006
EmailCustomerService@wishbonemedical.com
Phone(574) 306-4006
EmailCustomerService@wishbonemedical.com
Phone(574) 306-4006
EmailCustomerService@wishbonemedical.com
Phone(574) 306-4006
EmailCustomerService@wishbonemedical.com
Phone(574) 306-4006
EmailCustomerService@wishbonemedical.com
Phone(574) 306-4006
EmailCustomerService@wishbonemedical.com
Phone(574) 306-4006
EmailCustomerService@wishbonemedical.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB562501850203BLWB0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B562501850203BLWB0]

Moist Heat or Steam Sterilization


[B562501850203BLWB0]

Moist Heat or Steam Sterilization


[B562501850203BLWB0]

Moist Heat or Steam Sterilization


[B562501850203BLWB0]

Moist Heat or Steam Sterilization


[B562501850203BLWB0]

Moist Heat or Steam Sterilization


[B562501850203BLWB0]

Moist Heat or Steam Sterilization


[B562501850203BLWB0]

Moist Heat or Steam Sterilization


[B562501850203BLWB0]

Moist Heat or Steam Sterilization


[B562501850203BLWB0]

Moist Heat or Steam Sterilization


[B562501850203BLWB0]

Moist Heat or Steam Sterilization


[B562501850203BLWB0]

Moist Heat or Steam Sterilization


[B562501850203BLWB0]

Moist Heat or Steam Sterilization


[B562501850203BLWB0]

Moist Heat or Steam Sterilization


[B562501850203BLWB0]

Moist Heat or Steam Sterilization


[B562501850203BLWB0]

Moist Heat or Steam Sterilization


[B562501850203BLWB0]

Moist Heat or Steam Sterilization


[B562501850203BLWB0]

Moist Heat or Steam Sterilization


[B562501850203BLWB0]

Moist Heat or Steam Sterilization


[B562501850203BLWB0]

Moist Heat or Steam Sterilization


[B562501850203BLWB0]

Moist Heat or Steam Sterilization


[B562501850203BLWB0]

Moist Heat or Steam Sterilization


[B562501850203BLWB0]

Moist Heat or Steam Sterilization


[B562501850203BLWB0]

Moist Heat or Steam Sterilization


[B562501850203BLWB0]

Moist Heat or Steam Sterilization


[B562501850203BLWB0]

Moist Heat or Steam Sterilization


[B562501850203BLWB0]

Moist Heat or Steam Sterilization


[B562501850203BLWB0]

Moist Heat or Steam Sterilization


[B562501850203BLWB0]

Moist Heat or Steam Sterilization


[B562501850203BLWB0]

Moist Heat or Steam Sterilization


[B562501850203BLWB0]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-02-10
Device Publish Date2023-02-02

On-Brand Devices [Smart Correction]

B562SCSTRUTCASENSE0Smart Correction Strut Case
B562SCS0000Smart Correction Loaner Set
B562SCRINGCASE2NSE0Smart Correction Two Third and Foot Ring Case
B562SCRINGCASE1NSE0Smart Correction Full Ring Case
B562SCPINCASENSE0Smart Correction Pins and Wires Case
B562SCINSTCASE2NSE0Smart Correction Instruments Case 2
B562SCINSTCASE1NSE0Smart Correction Instruments Case 1
B562SCCLAMPCASENSE0Smart Correction Clamps and Bolts Case
B562C2C20210Click2Correct/ Smart Correction software
B5625060PC06NS0Half Pin Covers, 6mm (6 pack) - Non-Sterile
B562501860255SWBNS0Half Pin, 6.0/250/50mm, Self Drilling, QC, SS - Non-Sterile
B562501860254SWBNS0Half Pin, 6.0/250/40mm, Self Drilling, QC, SS - Non-Sterile
B562501860254BLWBNS0Half Pin, 6.0/250/40mm, Blunt Self Tapping, QC, SS - Non-Sterile
B562501860253SWBNS0Half Pin, 6.0/250/30mm, Self Drilling, QC, SS - Non-Sterile
B562501860253BLWBNS0Half Pin, 6.0/250/30mm, Blunt Self Tapping, QC, SS - Non-Sterile
B562501860225SWBNS0Half Pin, 6.0/220/50mm, Self Drilling, QC, SS - Non-Sterile
B562501860224SWBNS0Half Pin, 6.0/220/40mm, Self Drilling, QC, SS - Non-Sterile
B562501860224BLWBNS0Half Pin, 6.0/220/40mm, Blunt Self Tapping, QC, SS - Non-Sterile
B562501860223SWBNS0Half Pin, 6.0/220/30mm, Self Drilling, QC, SS - Non-Sterile
B562501860223BLWBNS0Half Pin, 6.0/220/30mm, Blunt Self Tapping, QC, SS - Non-Sterile
B562501860205SWBNS0Half Pin, 6.0/200/50mm, Self Drilling, QC, SS - Non-Sterile
B562501860205BLWBNS0Half Pin, 6.0/200/50mm, Blunt Self Tapping, QC, SS - Non-Sterile
B562501860204SWBNS0Half Pin, 6.0/200/40mm, Self Drilling, QC, SS - Non-Sterile
B562501860204BLWBNS0Half Pin, 6.0/200/40mm, Blunt Self Tapping, QC, SS - Non-Sterile
B562501860203SWBNS0Half Pin, 6.0/200/30mm, Self Drilling, QC, SS - Non-Sterile
B562501860203BLWBNS0Half Pin, 6.0/200/30mm, Blunt Self Tapping, QC, SS - Non-Sterile
B562501860184SWBNS0Half Pin, 6.0/180/40mm, Self Drilling, QC, SS - Non-Sterile
B562501860184BLWBNS0Half Pin, 6.0/180/40mm, Blunt Self Tapping, QC, SS - Non-Sterile
B562501860183SWBNS0Half Pin, 6.0/180/30mm, Self Drilling, QC, SS - Non-Sterile
B562501860183BLWBNS0Half Pin, 6.0/180/30mm, Blunt Self Tapping, QC, SS - Non-Sterile
B562501860154SWBNS0Half Pin, 6.0/150/40mm, Self Drilling, QC, SS - Non-Sterile
B562501860154BLWBNS0Half Pin, 6.0/150/40mm, Blunt Self Tapping, QC, SS - Non-Sterile
B562501860153SWBNS0Half Pin, 6.0/150/30mm, Self Drilling, QC, SS - Non-Sterile
B562501860153BLWBNS0Half Pin, 6.0/150/30mm, Blunt Self Tapping, QC, SS - Non-Sterile
B562501850255SWBNS0Half Pin, 5.0/250/50mm, Self Drilling, QC, SS - Non-Sterile
B562501850255BLWBNS0Half Pin, 5.0/250/50mm, Blunt Self Tapping, QC, SS - Non-Sterile
B562501850254SWBNS0Half Pin, 5.0/250/40mm, Self Drilling, QC, SS - Non-Sterile
B562501850254BLWBNS0Half Pin, 5.0/250/40mm, Blunt Self Tapping, QC, SS - Non-Sterile
B562501850253SWBNS0Half Pin, 5.0/250/30mm, Self Drilling, QC, SS - Non-Sterile
B562501850253BLWBNS0Half Pin, 5.0/250/30mm, Blunt Self Tapping, QC, SS - Non-Sterile
B562501850225SWBNS0Half Pin, 5.0/220/50mm, Self Drilling, QC, SS - Non-Sterile
B562501850225BLWBNS0Half Pin, 5.0/220/50mm, Blunt Self Tapping, QC, SS - Non-Sterile
B562501850224SWBNS0Half Pin, 5.0/220/40mm, Self Drilling, QC, SS - Non-Sterile
B562501850224BLWBNS0Half Pin, 5.0/220/40mm, Blunt Self Tapping, QC, SS - Non-Sterile
B562501850223SWBNS0Half Pin, 5.0/220/30mm, Self Drilling, QC, SS - Non-Sterile
B562501850223BLWBNS0Half Pin, 5.0/220/30mm, Blunt Self Tapping, QC, SS - Non-Sterile
B562501850205SWBNS0Half Pin, 5.0/200/50mm, Self Drilling, QC, SS - Non-Sterile
B562501850205BLWBNS0Half Pin, 5.0/200/50mm, Blunt Self Tapping, QC, SS - Non-Sterile
B562501850204SWBNS0Half Pin, 5.0/200/40mm, Self Drilling, QC, SS - Non-Sterile
B562501850204BLWBNS0Half 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
SMART CORRECTION
97888972 not registered Live/Pending
Wishbone Medical, Inc.
2023-04-14
SMART CORRECTION
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.