PSS System SLPL8100

GUDID 00840019914222

8.5mm x 100mm SureLOK Polyaxial Screw Long Arm

PRECISION SPINE, INC.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00840019914222
• NIH Device Record Key: 63a8a06a-4ae0-4646-b0e2-9c187f4826d1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PSS System
• Version Model Number: SLPL8100
• Catalog Number: SLPL8100
• Company DUNS: 079398589
• Company Name: PRECISION SPINE, 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840019914222 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092128

FDA Product Code

• MNH: Orthosis, Spondylolisthesis Spinal Fixation

Sterilization

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

[00840019914222]

Moist Heat or Steam Sterilization

[00840019914222]

Moist Heat or Steam Sterilization

[00840019914222]

Moist Heat or Steam Sterilization

[00840019914222]

Moist Heat or Steam Sterilization

[00840019914222]

Moist Heat or Steam Sterilization

[00840019914222]

Moist Heat or Steam Sterilization

[00840019914222]

Moist Heat or Steam Sterilization

[00840019914222]

Moist Heat or Steam Sterilization

[00840019914222]

Moist Heat or Steam Sterilization

[00840019914222]

Moist Heat or Steam Sterilization

[00840019914222]

Moist Heat or Steam Sterilization

[00840019914222]

Moist Heat or Steam Sterilization

[00840019914222]

Moist Heat or Steam Sterilization

[00840019914222]

Moist Heat or Steam Sterilization

[00840019914222]

Moist Heat or Steam Sterilization

[00840019914222]

Moist Heat or Steam Sterilization

[00840019914222]

Moist Heat or Steam Sterilization

[00840019914222]

Moist Heat or Steam Sterilization

[00840019914222]

Moist Heat or Steam Sterilization

[00840019914222]

Moist Heat or Steam Sterilization

[00840019914222]

Moist Heat or Steam Sterilization

[00840019914222]

Moist Heat or Steam Sterilization

[00840019914222]

Moist Heat or Steam Sterilization

[00840019914222]

Moist Heat or Steam Sterilization

[00840019914222]

Moist Heat or Steam Sterilization

[00840019914222]

Moist Heat or Steam Sterilization

[00840019914222]

Moist Heat or Steam Sterilization

[00840019914222]

Moist Heat or Steam Sterilization

[00840019914222]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-05-10
• Device Publish Date: 2019-05-02

On-Brand Devices [PSS System]

• 00840019931779: Ø8.5 x 100mm Cannulated Reduction Pedicle Screw
• 00840019931762: Ø8.5 x 90mm Cannulated Reduction Pedicle Screw
• 00840019931755: Ø8.5 x 80mm Cannulated Reduction Pedicle Screw
• 00840019931748: Ø8.5 x 70mm Cannulated Reduction Pedicle Screw
• 00840019931731: Ø8.5 x 60mm Cannulated Reduction Pedicle Screw
• 00840019931724: Ø8.5 x 55mm Cannulated Reduction Pedicle Screw
• 00840019931700: Ø8.5 x 45mm Cannulated Reduction Pedicle Screw
• 00840019931694: Ø8.5 x 40mm Cannulated Reduction Pedicle Screw
• 00840019931687: Ø8.5 x 35mm Cannulated Reduction Pedicle Screw
• 00840019931670: Ø8.5 x 30mm Cannulated Reduction Pedicle Screw
• 00840019931663: Ø8.5 x 25mm Cannulated Reduction Pedicle Screw
• 00840019931656: Ø7.5 x 60mm Cannulated Reduction Pedicle Screw
• 00840019931649: Ø7.5 x 55mm Cannulated Reduction Pedicle Screw
• 00840019931632: Ø7.5 x 50mm Cannulated Reduction Pedicle Screw
• 00840019931625: Ø7.5 x 45mm Cannulated Reduction Pedicle Screw
• 00840019931618: Ø7.5 x 40mm Cannulated Reduction Pedicle Screw
• 00840019931595: Ø7.5 x 30mm Cannulated Reduction Pedicle Screw
• 00840019931571: Ø6.5 x 60mm Cannulated Reduction Pedicle Screw
• 00840019931564: Ø6.5 x 55mm Cannulated Reduction Pedicle Screw
• 00840019931557: Ø6.5 x 50mm Cannulated Reduction Pedicle Screw
• 00840019931533: Ø6.5 x 40mm Cannulated Reduction Pedicle Screw
• 00840019931519: Ø6.5 x 30mm Cannulated Reduction Pedicle Screw
• 00840019931502: Ø6.5 x 25mm Cannulated Reduction Pedicle Screw
• 00840019931496: Ø5.5 x 60mm Cannulated Reduction Pedicle Screw
• 00840019931489: Ø5.5 x 55mm Cannulated Reduction Pedicle Screw
• 00840019931472: Ø5.5 x 50mm Cannulated Reduction Pedicle Screw
• 00840019931465: Ø5.5 x 45mm Cannulated Reduction Pedicle Screw
• 00840019931458: Ø5.5 x 40mm Cannulated Reduction Pedicle Screw
• 00840019931434: Ø5.5 x 30mm Cannulated Reduction Pedicle Screw
• 00840019931410: Ø8.5 x 100mm Cannulated Pedicle Screw
• 00840019931403: Ø8.5 x 90mm Cannulated Pedicle Screw
• 00840019931397: Ø8.5 x 80mm Cannulated Pedicle Screw
• 00840019931380: Ø8.5 x 70mm Cannulated Pedicle Screw
• 00840019931366: Ø8.5 x 55mm Cannulated Pedicle Screw
• 00840019931359: Ø8.5 x 50mm Cannulated Pedicle Screw
• 00840019931342: Ø8.5 x 45mm Cannulated Pedicle Screw
• 00840019931335: Ø8.5 x 40mm Cannulated Pedicle Screw
• 00840019931328: Ø8.5 x 35mm Cannulated Pedicle Screw
• 00840019931311: Ø8.5 x 30mm Cannulated Pedicle Screw
• 00840019931304: Ø8.5 x 25mm Cannulated Pedicle Screw
• 00840019931298: Ø7.5 x 60mm Cannulated Pedicle Screw
• 00840019931243: Ø7.5 x 35mm Cannulated Pedicle Screw
• 00840019931236: Ø7.5 x 30mm Cannulated Pedicle Screw
• 00840019931229: Ø7.5 x 25mm Cannulated Pedicle Screw
• 00840019931212: Ø6.5 x 60mm Cannulated Pedicle Screw
• 00840019931199: Ø6.5 x 50mm Cannulated Pedicle Screw
• 00840019931168: Ø6.5 x 35mm Cannulated Pedicle Screw
• 00840019931151: Ø6.5 x 30mm Cannulated Pedicle Screw
• 00840019931144: Ø6.5 x 25mm Cannulated Pedicle Screw
• 00840019931113: Ø5.5 x 50mm Cannulated Pedicle Screw