ORION WEDGE HTR-04-204112

GUDID 00841742140964

ORION Ti PEEK EVANS Wedge - 20x20x12mm

HNM TOTAL RECON LLC

Polymeric osteotomy fusion cage

• Primary Device ID: 00841742140964
• NIH Device Record Key: f341e219-78bf-4f0d-97ee-2b46a355594b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ORION WEDGE
• Version Model Number: HTR-04-204112
• Catalog Number: HTR-04-204112
• Company DUNS: 080024940
• Company Name: HNM TOTAL RECON LLC
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841742140964 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150394

FDA Product Code

• PLF: Bone Wedge

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: 2017-06-30

On-Brand Devices [ORION WEDGE]

• 00841742142227: ORION Ti PEEK COTTON Wedge - 20x14x6.5mm
• 00841742142210: ORION Ti PEEK COTTON Wedge - 20x14x5.5mm
• 00841742142203: ORION Ti PEEK COTTON Wedge - 20x14x4.5mm
• 00841742142197: ORION Ti PEEK COTTON Wedge - 16x14x6.5mm
• 00841742142180: ORION Ti PEEK COTTON Wedge - 16x14x5.5mm
• 00841742142173: ORION Ti PEEK COTTON Wedge - 16x14x4.5mm
• 00841742142166: ORION Ti PEEK EVANS Wedge - 22x22x12mm
• 00841742142159: ORION Ti PEEK EVANS Wedge - 22x22x10mm
• 00841742142142: ORION Ti PEEK EVANS Wedge - 22x22x8mm
• 00841742140964: ORION Ti PEEK EVANS Wedge - 20x20x12mm
• 00841742124469: ORION Ti PEEK EVANS Wedge - 20x20x10mm
• 00841742124452: ORION Ti PEEK EVANS Wedge - 20x20x8mm
• 00841742124445: ORION Ti PEEK EVANS Wedge - 18x18x12mm
• 00841742124438: ORION Ti PEEK EVANS Wedge - 18x18x10mm
• 00841742124414: ORION Ti PEEK EVANS Wedge - 18x18x8mm