POLARIS HTR-02-021018

GUDID 00841742113302

POLARIS ø4.0mm/ø3.0mm High Compression Screw, Cannulated, Ti - (L)18mm

HNM TOTAL RECON LLC

Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: 00841742113302
• NIH Device Record Key: c9a82a51-f079-42ee-9cc2-ff37cab8a286
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: POLARIS
• Version Model Number: HTR-02-021018
• Catalog Number: HTR-02-021018
• Company DUNS: 080024940
• Company Name: HNM TOTAL RECON LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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	00841742113302 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102845

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

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

[00841742113302]

Moist Heat or Steam Sterilization

[00841742113302]

Moist Heat or Steam Sterilization

[00841742113302]

Moist Heat or Steam Sterilization

[00841742113302]

Moist Heat or Steam Sterilization

[00841742113302]

Moist Heat or Steam Sterilization

[00841742113302]

Moist Heat or Steam Sterilization

[00841742113302]

Moist Heat or Steam Sterilization

[00841742113302]

Moist Heat or Steam Sterilization

[00841742113302]

Moist Heat or Steam Sterilization

[00841742113302]

Moist Heat or Steam Sterilization

[00841742113302]

Moist Heat or Steam Sterilization

[00841742113302]

Moist Heat or Steam Sterilization

[00841742113302]

Moist Heat or Steam Sterilization

[00841742113302]

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: 2016-09-30

On-Brand Devices [POLARIS]

• 00841742113609: POLARIS ø2.0mm Snap-Off Screw, Ti - (L)17mm
• 00841742113593: POLARIS ø2.0mm Snap-Off Screw, Ti - (L)16mm
• 00841742113586: POLARIS ø2.0mm Snap-Off Screw, Ti - (L)15mm
• 00841742113579: POLARIS ø2.0mm Snap-Off Screw, Ti - (L)14mm
• 00841742113562: POLARIS ø2.0mm Snap-Off Screw, Ti - (L)13mm
• 00841742113555: POLARIS ø2.0mm Snap-Off Screw, Ti - (L)12mm
• 00841742113548: POLARIS ø2.0mm Snap-Off Screw, Ti - (L)11mm
• 00841742113531: POLARIS ø2.0mm Snap-Off Screw, Ti - (L)10mm
• 00841742113524: POLARIS ø3.2mm/ø2.5mm Micro High Compression Screw, Cannulated, Ti - (L)30mm
• 00841742113517: POLARIS ø3.2mm/ø2.5mm Micro High Compression Screw, Cannulated, Ti - (L)28mm
• 00841742113500: POLARIS ø3.2mm/ø2.5mm Micro High Compression Screw, Cannulated, Ti - (L)26mm
• 00841742113494: POLARIS ø3.2mm/ø2.5mm Micro High Compression Screw, Cannulated, Ti - (L)24mm
• 00841742113487: POLARIS ø3.2mm/ø2.5mm Micro High Compression Screw, Cannulated, Ti - (L)22mm
• 00841742113470: POLARIS ø3.2mm/ø2.5mm Micro High Compression Screw, Cannulated, Ti - (L)20mm
• 00841742113463: POLARIS ø3.2mm/ø2.5mm Micro High Compression Screw, Cannulated, Ti - (L)18mm
• 00841742113456: POLARIS ø3.2mm/ø2.5mm Micro High Compression Screw, Cannulated, Ti - (L)16mm
• 00841742113449: POLARIS ø3.2mm/ø2.5mm Micro High Compression Screw, Cannulated, Ti - (L)14mm
• 00841742113432: POLARIS ø3.2mm/ø2.5mm Micro High Compression Screw, Cannulated, Ti - (L)12mm
• 00841742113425: POLARIS ø3.2mm/ø2.5mm Micro High Compression Screw, Cannulated, Ti - (L)10mm
• 00841742113418: POLARIS ø4.0mm/ø3.0mm High Compression Screw, Cannulated, Ti - (L)40mm
• 00841742113401: POLARIS ø4.0mm/ø3.0mm High Compression Screw, Cannulated, Ti - (L)38mm
• 00841742113395: POLARIS ø4.0mm/ø3.0mm High Compression Screw, Cannulated, Ti - (L)36mm
• 00841742113388: POLARIS ø4.0mm/ø3.0mm High Compression Screw, Cannulated, Ti - (L)34mm
• 00841742113371: POLARIS ø4.0mm/ø3.0mm High Compression Screw, Cannulated, Ti - (L)32mm
• 00841742113364: POLARIS ø4.0mm/ø3.0mm High Compression Screw, Cannulated, Ti - (L)30mm
• 00841742113357: POLARIS ø4.0mm/ø3.0mm High Compression Screw, Cannulated, Ti - (L)28mm
• 00841742113340: POLARIS ø4.0mm/ø3.0mm High Compression Screw, Cannulated, Ti - (L)26mm
• 00841742113333: POLARIS ø4.0mm/ø3.0mm High Compression Screw, Cannulated, Ti - (L)24mm
• 00841742113326: POLARIS ø4.0mm/ø3.0mm High Compression Screw, Cannulated, Ti - (L)22mm
• 00841742113319: POLARIS ø4.0mm/ø3.0mm High Compression Screw, Cannulated, Ti - (L)20mm
• 00841742113302: POLARIS ø4.0mm/ø3.0mm High Compression Screw, Cannulated, Ti - (L)18mm
• 00841742113296: POLARIS ø4.0mm/ø3.0mm High Compression Screw, Cannulated, Ti - (L)16mm
• 00841742113289: POLARIS ø4.0mm/ø3.0mm High Compression Screw, Cannulated, Ti - (L)14mm
• 00841742113272: POLARIS ø4.0mm/ø3.0mm High Compression Screw, Cannulated, Ti - (L)12mm