Outologous Spinal Fixation System PS7040

GUDID 00813892020861

7.0 X 40mm Titanium Pedicle Screw Self Tapping

Orthopedic Sciences Inc

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00813892020861
• NIH Device Record Key: 112f6648-fe54-45b2-9300-2ce5920a1152
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Outologous Spinal Fixation System
• Version Model Number: PS7040
• Catalog Number: PS7040
• Company DUNS: 068109169
• Company Name: Orthopedic Sciences Inc
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(562)799-5550
• Email: info@orthopedicsciences.com
• Phone: +1(562)799-5550
• Email: info@orthopedicsciences.com

Device Dimensions

• Length: 40 Millimeter
• Length: 40 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 122 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813892020861 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K040493

FDA Product Code

• MNH: Orthosis, spondylolisthesis spinal fixation

Sterilization

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

[00813892020861]

Moist Heat or Steam Sterilization

[00813892020861]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-13

On-Brand Devices [Outologous Spinal Fixation System]

• 00813892021073: Cross Link Nut
• 00813892021066: Cross Link Hook
• 00813892021059: 80mm Cross Link
• 00813892021042: 70mm Cross Link
• 00813892021035: 60mm Cross Link
• 00813892021028: 50mm Cross Link
• 00813892021011: 40mm Cross Link
• 00813892021004: Set Screw
• 00813892020991: 6.0 x 150mm Titanium Rod
• 00813892020984: 6. 0x 120mm Titanium Rod
• 00813892020977: 6.0 x 100mm Titanium Rod
• 00813892020960: 6.0 x 90mm Titanium Rod
• 00813892020953: 6.0 x 80mm Titanium Rod
• 00813892020946: 6.0 x 70mm Titanium Rod
• 00813892020939: 6.0 x 60mm Titanium Rod
• 00813892020922: 6.0 x 50mm Titanium Rod
• 00813892020915: 6.0 x 40mm Titanium Rod
• 00813892020908: 7.0 X 60mm Titanium Pedicle Screw Self Tapping
• 00813892020892: 7.0 X 55mm Titanium Pedicle Screw Self Tapping
• 00813892020885: 7.0 X 50mm Titanium Pedicle Screw Self Tapping
• 00813892020878: 7.0 X 45mm Titanium Pedicle Screw Self Tapping
• 00813892020861: 7.0 X 40mm Titanium Pedicle Screw Self Tapping
• 00813892020854: 7.0 X 35mm Titanium Pedicle Screw Self Tapping
• 00813892020847: 7.0 X 30mm Titanium Pedicle Screw Self Tapping
• 00813892020830: 6.0 X 60mm Titanium Pedicle Screw Self Tapping
• 00813892020823: 6.0 X 55mm Titanium Pedicle Screw Self Tapping
• 00813892020816: 6.0 X 50mm Titanium Pedicle Screw Self Tapping
• 00813892020809: 6.0 X 45mmTitanium Pedicle Screw Self Tapping
• 00813892020793: 6.0 X 40mm Titanium Pedicle Screw Self Tapping
• 00813892020786: 6.0 X 35mm Titanium Pedicle Screw Self Tapping
• 00813892020779: 6.0 X 30mm Titanium Pedicle Screw Self Tapping