SCFE Screw 00-1071-8250

GUDID 00841132118023

3.5mm X 50mm SHORT THREADED CANNULATED CANCELLOUS SCREW

ORTHOPEDIATRICS CORP.

Growth-correction orthopaedic fixation plate kit

• Primary Device ID: 00841132118023
• NIH Device Record Key: 5597c98e-aa5b-4304-a049-32f07795ac03
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SCFE Screw
• Version Model Number: 00-1071-8250
• Catalog Number: 00-1071-8250
• Company DUNS: 796416191
• Company Name: ORTHOPEDIATRICS CORP.
• Device Count: 1
• DM Exempt: true
• 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: 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: +1(574)268-6379
• Email: Rbremer@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: Rbremer@orthopediatrics.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841132118023 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082949

FDA Product Code

• HRS: PLATE, FIXATION, BONE

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-09-08

On-Brand Devices [SCFE Screw]

• 00841132118047: 3.5mm X 60mm SHORT THREADED CANNULATED CANCELLOUS SCREW
• 00841132118030: 3.5mm X 55mm SHORT THREADED CANNULATED CANCELLOUS SCREW
• 00841132118023: 3.5mm X 50mm SHORT THREADED CANNULATED CANCELLOUS SCREW
• 00841132118016: 3.5mm X 48mm SHORT THREADED CANNULATED CANCELLOUS SCREW
• 00841132118009: 3.5mm X 46mm SHORT THREADED CANNULATED CANCELLOUS SCREW
• 00841132117996: 3.5mm X 44mm SHORT THREADED CANNULATED CANCELLOUS SCREW
• 00841132117989: 3.5mm X 42mm SHORT THREADED CANNULATED CANCELLOUS SCREW
• 00841132117972: 3.5mm X 40mm SHORT THREADED CANNULATED CANCELLOUS SCREW
• 00841132117965: 3.5mm X 38mm SHORT THREADED CANNULATED CANCELLOUS SCREW
• 00841132117958: 3.5mm X 36mm SHORT THREADED CANNULATED CANCELLOUS SCREW
• 00841132117941: 3.5mm X 34mm SHORT THREADED CANNULATED CANCELLOUS SCREW
• 00841132117934: 3.5mm X 32mm SHORT THREADED CANNULATED CANCELLOUS SCREW
• 00841132117927: 3.5mm X 30mm SHORT THREADED CANNULATED CANCELLOUS SCREW
• 00841132117910: 3.5mm X 28mm SHORT THREADED CANNULATED CANCELLOUS SCREW
• 00841132117903: 3.5mm X 26mm SHORT THREADED CANNULATED CANCELLOUS SCREW
• 00841132117897: 3.5mm X 24mm SHORT THREADED CANNULATED CANCELLOUS SCREW
• 00841132117880: 3.5mm X 22mm SHORT THREADED CANNULATED CANCELLOUS SCREW
• 00841132117873: 3.5mm X 20mm SHORT THREADED CANNULATED CANCELLOUS SCREW
• 00841132117866: 3.5mm X 18mm SHORT THREADED CANNULATED CANCELLOUS SCREW
• 00841132117859: 3.5mm X 16mm SHORT THREADED CANNULATED CANCELLOUS SCREW
• 00841132117842: 3.5mm X 14mm SHORT THREADED CANNULATED CANCELLOUS SCREW
• 00841132117835: 3.5mm X 12mm SHORT THREADED CANNULATED CANCELLOUS SCREW
• 00841132117828: 3.5mm X 10mm SHORT THREADED CANNULATED CANCELLOUS SCREW
• 00841132117811: 3.5mm X 60mm MEDIUM THREADED CANNULATED CANCELLOUS SCREW
• 00841132117804: 3.5mm X 55mm MEDIUM THREADED CANNULATED CANCELLOUS SCREW
• 00841132117798: 3.5mm X 50mm MEDIUM THREADED CANNULATED CANCELLOUS SCREW
• 00841132117781: 3.5mm X 48mm MEDIUM THREADED CANNULATED CANCELLOUS SCREW
• 00841132117774: 3.5mm X 46mm MEDIUM THREADED CANNULATED CANCELLOUS SCREW
• 00841132117767: 3.5mm X 44mm MEDIUM THREADED CANNULATED CANCELLOUS SCREW
• 00841132117750: 3.5mm X 42mm MEDIUM THREADED CANNULATED CANCELLOUS SCREW
• 00841132117743: 3.5mm X 40mm MEDIUM THREADED CANNULATED CANCELLOUS SCREW
• 00841132117736: 3.5mm X 38mm MEDIUM THREADED CANNULATED CANCELLOUS SCREW
• 00841132117729: 3.5mm X 36mm MEDIUM THREADED CANNULATED CANCELLOUS SCREW
• 00841132117712: 3.5mm X 34mm MEDIUM THREADED CANNULATED CANCELLOUS SCREW
• 00841132117705: 3.5mm X 32mm MEDIUM THREADED CANNULATED CANCELLOUS SCREW
• 00841132117699: 3.5mm X 30mm MEDIUM THREADED CANNULATED CANCELLOUS SCREW
• 00841132117682: 3.5mm X 60mm FULLY THREADED CANNULATED CANCELLOUS SCREW
• 00841132117675: 3.5mm X 55mm FULLY THREADED CANNULATED CANCELLOUS SCREW
• 00841132117668: 3.5mm X 50mm FULLY THREADED CANNULATED CANCELLOUS SCREW
• 00841132117651: 3.5mm X 48mm FULLY THREADED CANNULATED CANCELLOUS SCREW
• 00841132117644: 3.5mm X 46mm FULLY THREADED CANNULATED CANCELLOUS SCREW
• 00841132117637: 3.5mm X 44mm FULLY THREADED CANNULATED CANCELLOUS SCREW
• 00841132117620: 3.5mm X 42mm FULLY THREADED CANNULATED CANCELLOUS SCREW
• 00841132117613: 3.5mm X 40mm FULLY THREADED CANNULATED CANCELLOUS SCREW
• 00841132117606: 3.5mm X 38mm FULLY THREADED CANNULATED CANCELLOUS SCREW
• 00841132117590: 3.5mm X 36mm FULLY THREADED CANNULATED CANCELLOUS SCREW
• 00841132117583: 3.5mm X 34mm FULLY THREADED CANNULATED CANCELLOUS SCREW
• 00841132117576: 3.5mm X 32mm FULLY THREADED CANNULATED CANCELLOUS SCREW
• 00841132117569: 3.5mm X 30mm FULLY THREADED CANNULATED CANCELLOUS SCREW
• 00841132117552: 3.5mm X 28mm FULLY THREADED CANNULATED CANCELLOUS SCREW