FlexitSystem PTS001-7

GUDID 03701173701479

Opening wedge HTO Symmetrical Plate Size 2

NEOSTEO

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile

• Primary Device ID: 03701173701479
• NIH Device Record Key: 0ec4e7db-1ba9-48db-92e3-4c369fa43cfd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FlexitSystem
• Version Model Number: PTS001-7
• Catalog Number: PTS001-7
• Company DUNS: 261106831
• Company Name: NEOSTEO
• 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: 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 Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Device must be stored in a place protected from light and humidity.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Device must be stored in a place protected from light and humidity.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Device must be stored in a place protected from light and humidity.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Device must be stored in a place protected from light and humidity.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Device must be stored in a place protected from light and humidity.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Device must be stored in a place protected from light and humidity.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Device must be stored in a place protected from light and humidity.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Device must be stored in a place protected from light and humidity.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Device must be stored in a place protected from light and humidity.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Device must be stored in a place protected from light and humidity.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Device must be stored in a place protected from light and humidity.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Device must be stored in a place protected from light and humidity.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Device must be stored in a place protected from light and humidity.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Device must be stored in a place protected from light and humidity.

Device Identifiers

Device Issuing Agency	Device ID
GS1	03701173701479 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212545

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-05-10
• Device Publish Date: 2022-05-02

On-Brand Devices [FlexitSystem]

• 03701173701943: Locking screw, Ø5mm length 80mm
• 03701173701929: Locking screw, Ø5mm length 75mm
• 03701173701905: Locking screw, Ø5mm length 70mm
• 03701173701882: Locking screw, Ø5mm length 65mm
• 03701173701868: Locking screw, Ø5mm length 60mm
• 03701173701844: Locking screw, Ø5mm length 55mm
• 03701173701820: Locking screw, Ø5mm length 50mm
• 03701173701806: Locking screw, Ø5mm length 45mm
• 03701173701783: Locking screw, Ø5mm length 40mm
• 03701173701769: Locking screw, Ø5mm length 35mm
• 03701173701745: Locking screw, Ø5mm length 30mm
• 03701173701721: Locking screw, Ø5mm length 25mm
• 03701173701486: emoral osteotomy plate
• 03701173701479: Opening wedge HTO Symmetrical Plate Size 2
• 03701173701462: Opening wedge HTO Symmetrical Plate Size 1
• 03701173701448: Closing wedge HTO Left Plate
• 03701173701431: Closing wedge HTO Right Plate