OTIS-C PLUS EVO9066027

GUDID 03760154001175

316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate.

S.B.M

Orthopaedic bone screw, non-bioabsorbable, sterile

• Primary Device ID: 03760154001175
• NIH Device Record Key: 753f506d-d3da-41f0-9186-b1f239f9e770
• Commercial Distribution Discontinuation: 2020-01-09
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: OTIS-C PLUS
• Version Model Number: Screw for OTIS-C PLUS plate fixation
• Catalog Number: EVO9066027
• Company DUNS: 772462123
• Company Name: S.B.M
• 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

Customer Support Contacts

• Phone: 781-369-1782
• Email: gboue@s-b-m.us
• Phone: 781-369-1782
• Email: gboue@s-b-m.us
• Phone: 781-369-1782
• Email: gboue@s-b-m.us
• Phone: 781-369-1782
• Email: gboue@s-b-m.us
• Phone: 781-369-1782
• Email: gboue@s-b-m.us
• Phone: 781-369-1782
• Email: gboue@s-b-m.us
• Phone: 781-369-1782
• Email: gboue@s-b-m.us
• Phone: 781-369-1782
• Email: gboue@s-b-m.us
• Phone: 781-369-1782
• Email: gboue@s-b-m.us
• Phone: 781-369-1782
• Email: gboue@s-b-m.us
• Phone: 781-369-1782
• Email: gboue@s-b-m.us
• Phone: 781-369-1782
• Email: gboue@s-b-m.us
• Phone: 781-369-1782
• Email: gboue@s-b-m.us
• Phone: 781-369-1782
• Email: gboue@s-b-m.us
• Phone: 781-369-1782
• Email: gboue@s-b-m.us
• Phone: 781-369-1782
• Email: gboue@s-b-m.us
• Phone: 781-369-1782
• Email: gboue@s-b-m.us
• Phone: 781-369-1782
• Email: gboue@s-b-m.us
• Phone: 781-369-1782
• Email: gboue@s-b-m.us
• Phone: 781-369-1782
• Email: gboue@s-b-m.us
• Phone: 781-369-1782
• Email: gboue@s-b-m.us
• Phone: 781-369-1782
• Email: gboue@s-b-m.us
• Phone: 781-369-1782
• Email: gboue@s-b-m.us
• Phone: 781-369-1782
• Email: gboue@s-b-m.us
• Phone: 781-369-1782
• Email: gboue@s-b-m.us
• Phone: 781-369-1782
• Email: gboue@s-b-m.us
• Phone: 781-369-1782
• Email: gboue@s-b-m.us
• Phone: 781-369-1782
• Email: gboue@s-b-m.us
• Phone: 781-369-1782
• Email: gboue@s-b-m.us
• Phone: 781-369-1782
• Email: gboue@s-b-m.us
• Phone: 781-369-1782
• Email: gboue@s-b-m.us
• Phone: 781-369-1782
• Email: gboue@s-b-m.us
• Phone: 781-369-1782
• Email: gboue@s-b-m.us
• Phone: 781-369-1782
• Email: gboue@s-b-m.us
• Phone: 781-369-1782
• Email: gboue@s-b-m.us

Device Dimensions

• Outer Diameter: 6.5 Millimeter
• Length: 27 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 27 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 27 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 27 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 27 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 27 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 27 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 27 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 27 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 27 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 27 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 27 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 27 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 27 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 27 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 27 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 27 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 27 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 27 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 27 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 27 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 27 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 27 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 27 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 27 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 27 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 27 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 27 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 27 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 27 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 27 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 27 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 27 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 27 Millimeter
• Outer Diameter: 6.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	03760154001175 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100604

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-01-10
• Device Publish Date: 2015-10-16

On-Brand Devices [OTIS-C PLUS]

• 03760154004794: NON STERILE 316L stainless mini-invasive OTIS-C PLUS plate.
• 03760154004770: NON STERILE 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate.
• 03760154004756: NON STERILE 316L stainless mini-invasive OTIS-C PLUS plate.
• 03760154004749: NON STERILE 316L stainless mini-invasive OTIS-C PLUS plate.
• 03760154004732: NON STERILE 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate.
• 03760154004718: NON STERILE 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate.
• 03760154004701: NON STERILE 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate.
• 03760154004695: NON STERILE 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate.
• 03760154004497: NON STERILE 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate.
• 03760154004480: NON STERILE 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate.
• 03760154004459: NON STERILE 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate.
• 03760154004190: NON STERILE 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate.
• 03760154004169: NON STERILE 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate.
• 03760154004152: NON STERILE 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate. https://gu
• 03760154004145: NON STERILE 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate.
• 03760154007924: 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate.
• 03760154005142: 316L stainless steel mini-invasive, anatomically shaped plate for HTO. To be used with OTIS-C Pl
• 03760154005135: 316L stainless steel mini-invasive, anatomically shaped plate for HTO. To be used with OTIS-C Pl
• 03760154001397: 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate.
• 03760154001281: 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate.
• 03760154001274: 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate.
• 03760154001267: 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate.
• 03760154001250: 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate.
• 03760154001243: 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate.
• 03760154001236: 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate.
• 03760154001229: 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate.
• 03760154001212: 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate.
• 03760154001205: 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate.
• 03760154001199: 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate.
• 03760154001182: 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate.
• 03760154001175: 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate.
• 03760154001113: Screw for temporary fixation of OTIS-C PLUS osteosynthesis plate for HTO.