SImmetry® 10-P12545-01

GUDID 00817672010356

SIJ Implant 12.5mm X 45mm

ZYGA TECHNOLOGY, INC.

Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile

• Primary Device ID: 00817672010356
• NIH Device Record Key: 419141e7-3ea9-48b3-8142-23484b04bb5d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SImmetry®
• Version Model Number: 10-P12545-01
• Catalog Number: 10-P12545-01
• Company DUNS: 024049072
• Company Name: ZYGA TECHNOLOGY, INC.
• 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: 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 Identifiers

Device Issuing Agency	Device ID
GS1	00817672010356 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141549

FDA Product Code

• OUR: Sacroiliac Joint Fixation

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-15

On-Brand Devices [SImmetry®]

• 00817672011667: SIJ Washer For Use with SImmetry® SIJ Implant 14.5mm
• 00817672011650: SIJ Washer For Use with SImmetry® SIJ Implant 12.5mm
• 00817672011643: SIJ Washer For Use with SImmetry® SIJ Implant 10.5mm
• 00817672011636: SIJ Washer For Use with SImmetry® SIJ Implant 8.5mm
• 00817672011391: SIJ Implant 14.5mm X 60mm
• 00817672011384: SIJ Implant 14.5mm X 55mm
• 00817672011377: SIJ Implant 14.5mm X 50mm
• 00817672011360: SIJ Implant 14.5mm X 45mm
• 00817672011353: SIJ Implant 14.5mm X 40mm
• 00817672011285: SIJ Implant 12.5mm X 90mm
• 00817672011261: SIJ Implant 12.5mm X 80mm
• 00817672011247: SIJ Implant 12.5mm X 70mm
• 00817672011223: SIJ Implant 12.5mm X 60mm
• 00817672011155: SIJ Implant 10.5mm X 90mm
• 00817672011131: SIJ Implant 10.5mm X 80mm
• 00817672011117: SIJ Implant 10.5mm X 70mm
• 00817672011094: SIJ Implant 10.5mm X 60mm
• 00817672011018: SIJ Implant 10.5mm X 90mm
• 00817672010998: SIJ Implant 10.5mm X 80mm
• 00817672010974: SIJ Implant 10.5mm X 70mm
• 00817672010950: SIJ Implant 10.5mm X 60mm
• 00817672010936: SIJ Implant 10.5mm X 50mm
• 00817672010844: SIJ Implant 8.5mm X 90mm
• 00817672010820: SIJ Implant 8.5mm X 80mm
• 00817672010806: SIJ Implant 8.5mm X 70mm
• 00817672010585: SIJ Implant 8.5mm X 90mm
• 00817672010561: SIJ Implant 8.5mm X 80mm
• 00817672010547: SIJ Implant 8.5mm X 70mm
• 00817672010523: SIJ Implant 8.5mm X 60mm
• 00817672010516: SIJ Implant 8.5mm X 55mm
• 00817672010509: SIJ Implant 8.5mm X 50mm
• 00817672010493: SIJ Implant 8.5mm X 45mm
• 00817672010486: SIJ Implant 8.5mm X 40mm
• 00817672010417: SIJ Implant 12.5mm X 90mm
• 00817672010394: SIJ Implant 12.5mm X 80mm
• 00817672010363: SIJ Implant 12.5mm X 55mm
• 00817672010356: SIJ Implant 12.5mm X 45mm
• 00817672010097: SIJ Implant 12.5mm X 70mm
• 00817672010080: SIJ Implant 12.5mm X 60mm
• 00817672010073: SIJ Implant 12.5mm X 50mm
• 00817672010066: SIJ Implant 12.5mm X 40mm