NEOTIS EVO9067402

GUDID 03760154001939

NEOTIS plates are intended to be used in conjunction with bone screws to provide fixation following proximal tibial opening wedge osteotomies.

S.B.M

Orthopaedic fixation plate, non-bioabsorbable, sterile

• Primary Device ID: 03760154001939
• NIH Device Record Key: 7232af01-59cb-41f2-89ca-7ab2c1c1b64a
• Commercial Distribution Discontinuation: 2020-01-09
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: NEOTIS
• Version Model Number: NEOTIS Plate - Left
• Catalog Number: EVO9067402
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	03760154001939 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140226

FDA Product Code

• HRS: Plate, 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: 5
• Public Version Date: 2020-01-10
• Device Publish Date: 2015-10-14

On-Brand Devices [NEOTIS]

• 03760154002318: Wedge shaped implant for HTO - Absorbable calcium salt bone void filler 45% porosity
• 03760154001977: Wedge shaped implant for HTO - Absorbable calcium salt bone void filler 30% porosity
• 03760154002301: Wedge shaped implant for HTO - Absorbable calcium salt bone void filler 45% porosity
• 03760154002288: Wedge shaped implant for HTO - Absorbable calcium salt bone void filler 45% porosity
• 03760154002219: Wedge shaped implant for HTO - Absorbable calcium salt bone void filler 45% porosity
• 03760154002158: Wedge shaped implant for HTO - Absorbable calcium salt bone void filler 45% porosity
• 03760154002042: Wedge shaped implant for HTO - Absorbable calcium salt bone void filler 45% porosity
• 03760154002028: Wedge shaped implant for HTO - Absorbable calcium salt bone void filler 45% porosity
• 03760154001991: Wedge shaped implant for HTO - Absorbable calcium salt bone void filler 45% porosity
• 03760154001960: Wedge shaped implant for HTO - Absorbable calcium salt bone void filler 30% porosity
• 03760154001953: Wedge shaped implant for HTO - Absorbable calcium salt bone void filler 30% porosity
• 03760154001946: Wedge shaped implant for HTO - Absorbable calcium salt bone void filler 30% porosity
• 03760154001939: NEOTIS plates are intended to be used in conjunction with bone screws to provide fixation follow
• 03760154001922: NEOTIS plates are intended to be used in conjunction with bone screws to provide fixation follow
• 03760304680496: Wedge shaped implant for HTO - Absorbable calcium salt bone void filler 45% porosity
• 03760304680489: Wedge shaped implant for HTO - Absorbable calcium salt bone void filler 45% porosity
• 03760304680472: Wedge shaped implant for HTO - Absorbable calcium salt bone void filler 45% porosity
• 03760304680465: Wedge shaped implant for HTO - Absorbable calcium salt bone void filler 45% porosity
• 03760304680458: Wedge shaped implant for HTO - Absorbable calcium salt bone void filler 45% porosity
• 03760304680441: Wedge shaped implant for HTO - Absorbable calcium salt bone void filler 45% porosity
• 03760304680434: Wedge shaped implant for HTO - Absorbable calcium salt bone void filler 45% porosity
• 03760304680427: Wedge shaped implant for HTO - Absorbable calcium salt bone void filler 30% porosity
• 03760304680410: Wedge shaped implant for HTO - Absorbable calcium salt bone void filler 30% porosity
• 03760304680403: Wedge shaped implant for HTO - Absorbable calcium salt bone void filler 30% porosity