ORION HTR-04-254222

GUDID 00841742144634

ORION ø2.5mm Headed Cannulated Screw, Long Thread, Ti - (L)22mm

HNM TOTAL RECON LLC

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

• Primary Device ID: 00841742144634
• NIH Device Record Key: 471917ee-98d2-4f3a-9fc7-ff4ffafa7713
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ORION
• Version Model Number: HTR-04-254222
• Catalog Number: HTR-04-254222
• 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: false
• 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	00841742144634 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153575

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

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

[00841742144634]

Moist Heat or Steam Sterilization

[00841742144634]

Moist Heat or Steam Sterilization

[00841742144634]

Moist Heat or Steam Sterilization

[00841742144634]

Moist Heat or Steam Sterilization

[00841742144634]

Moist Heat or Steam Sterilization

[00841742144634]

Moist Heat or Steam Sterilization

[00841742144634]

Moist Heat or Steam Sterilization

[00841742144634]

Moist Heat or Steam Sterilization

[00841742144634]

Moist Heat or Steam Sterilization

[00841742144634]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-11-06
• Device Publish Date: 2020-10-29

On-Brand Devices [ORION]

• 00841742142135: ORION ø6.5mm Headless Cannulated Screw, Long Thread, Ti - (L)55mm
• 00841742142128: ORION ø6.5mm Headless Cannulated Screw, Short Thread, Ti - (L)55mm
• 00841742142111: ORION ø6.5mm Headless Cannulated Screw, Long Thread, Ti - (L)45mm
• 00841742142104: ORION ø6.5mm Headless Cannulated Screw, Short Thread, Ti - (L)45mm
• 00841742142098: ORION ø4.5mm Headless Cannulated Screw, Short Thread, Ti - (L)55mm
• 00841742142081: ORION ø4.5mm Headless Cannulated Screw, Short Thread, Ti - (L)55mm
• 00841742142074: ORION ø4.5mm Headless Cannulated Screw, Long Thread, Ti - (L)45mm
• 00841742142067: ORION ø4.5mm Headless Cannulated Screw, Short Thread, Ti - (L)45mm
• 00841742141237: ORION ø2.5mm Headless Cannulated Screw, Short Thread, Ti - (L)22mm
• 00841742141213: ORION ø2.5mm Headless Cannulated Screw, Short Thread, Ti - (L)20mm
• 00841742141190: ORION ø2.5mm Headless Cannulated Screw, Short Thread, Ti - (L)18mm
• 00841742141176: ORION ø2.5mm Headless Cannulated Screw, Short Thread, Ti - (L)16mm
• 00841742141152: ORION ø2.5mm Headless Cannulated Screw, Short Thread, Ti - (L)14mm
• 00841742141138: ORION ø2.5mm Headless Cannulated Screw, Short Thread, Ti - (L)12mm
• 00841742140957: ORION ø4.5mm Headed Cannulated Screw, Long Thread, Ti - (L)45mm
• 00841742121369: ORION ø6.5mm Headed Cannulated Screw, Long Thread, Ti - (L)120mm
• 00841742121352: ORION ø6.5mm Headed Cannulated Screw, Long Thread, Ti - (L)115mm
• 00841742121345: ORION ø6.5mm Headed Cannulated Screw, Long Thread, Ti - (L)110mm
• 00841742121338: ORION ø6.5mm Headed Cannulated Screw, Long Thread, Ti - (L)105mm
• 00841742121321: ORION ø6.5mm Headed Cannulated Screw, Long Thread, Ti - (L)100mm
• 00841742121314: ORION ø6.5mm Headed Cannulated Screw, Long Thread, Ti - (L)95mm
• 00841742121307: ORION ø6.5mm Headed Cannulated Screw, Long Thread, Ti - (L)90mm
• 00841742121291: ORION ø6.5mm Headed Cannulated Screw, Long Thread, Ti - (L)85mm
• 00841742121284: ORION ø6.5mm Headed Cannulated Screw, Long Thread, Ti - (L)80mm
• 00841742121277: ORION ø6.5mm Headed Cannulated Screw, Long Thread, Ti - (L)75mm
• 00841742121260: ORION ø6.5mm Headed Cannulated Screw, Long Thread, Ti - (L)70mm
• 00841742121253: ORION ø6.5mm Headed Cannulated Screw, Long Thread, Ti - (L)65mm
• 00841742121246: ORION ø6.5mm Headed Cannulated Screw, Long Thread, Ti - (L)60mm
• 00841742121239: ORION ø6.5mm Headed Cannulated Screw, Long Thread, Ti - (L)55mm
• 00841742121222: ORION ø6.5mm Headed Cannulated Screw, Long Thread, Ti - (L)50mm
• 00841742121215: ORION ø6.5mm Headed Cannulated Screw, Long Thread, Ti - (L)45mm
• 00841742121208: ORION ø6.5mm Headed Cannulated Screw, Long Thread, Ti - (L)40mm
• 00841742121192: ORION ø6.5mm Headed Cannulated Screw, Long Thread, Ti - (L)38mm
• 00841742121185: ORION ø6.5mm Headed Cannulated Screw, Long Thread, Ti - (L)36mm
• 00841742121178: ORION ø6.5mm Headed Cannulated Screw, Long Thread, Ti - (L)34mm
• 00841742121161: ORION ø6.5mm Headed Cannulated Screw, Long Thread, Ti - (L)32mm
• 00841742121154: ORION ø6.5mm Headed Cannulated Screw, Long Thread, Ti - (L)30mm
• 00841742121147: ORION ø6.5mm Headed Cannulated Screw, Short Thread, Ti - (L)120mm
• 00841742121130: ORION ø6.5mm Headed Cannulated Screw, Short Thread, Ti - (L)115mm
• 00841742121123: ORION ø6.5mm Headed Cannulated Screw, Short Thread, Ti - (L)110mm
• 00841742121116: ORION ø6.5mm Headed Cannulated Screw, Short Thread, Ti - (L)105mm
• 00841742121109: ORION ø6.5mm Headed Cannulated Screw, Short Thread, Ti - (L)100mm
• 00841742121093: ORION ø6.5mm Headed Cannulated Screw, Short Thread, Ti - (L)95mm
• 00841742121086: ORION ø6.5mm Headed Cannulated Screw, Short Thread, Ti - (L)90mm
• 00841742121079: ORION ø6.5mm Headed Cannulated Screw, Short Thread, Ti - (L)85mm
• 00841742121062: ORION ø6.5mm Headed Cannulated Screw, Short Thread, Ti - (L)80mm
• 00841742121055: ORION ø6.5mm Headed Cannulated Screw, Short Thread, Ti - (L)75mm
• 00841742121048: ORION ø6.5mm Headed Cannulated Screw, Short Thread, Ti - (L)70mm
• 00841742121031: ORION ø6.5mm Headed Cannulated Screw, Short Thread, Ti - (L)65mm
• 00841742121024: ORION ø6.5mm Headed Cannulated Screw, Short Thread, Ti - (L)60mm