DRACO HTR-03-010830

GUDID 00841742121796

DRACO MetaFuse L-Plate, Ti - (L)30mm, R

HNM TOTAL RECON LLC

Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile

• Primary Device ID: 00841742121796
• NIH Device Record Key: 57436762-577d-4d1a-9fa8-36ee38d12500
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DRACO
• Version Model Number: HTR-03-010830
• Catalog Number: HTR-03-010830
• 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: true
• 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	00841742121796 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K050457

FDA Product Code

• KTT: Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Sterilization

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

[00841742121796]

Moist Heat or Steam Sterilization

[00841742121796]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-19
• Device Publish Date: 2017-12-11

On-Brand Devices [DRACO]

• 00841742143583: DRACO ø2.0mm Twist-Cut Snap-Off Screw - (L)14mm
• 00841742143576: DRACO ø2.0mm Twist-Cut Snap-Off Screw - (L)13mm
• 00841742143569: DRACO ø2.0mm Twist-Cut Snap-Off Screw - (L)12mm
• 00841742143552: DRACO ø2.0mm Twist-Cut Snap-Off Screw - (L)11mm
• 00841742143545: DRACO ø4.3mm Cannnulated Headless Compression Screw, Partially Thread, Ti - (L)55mm, Torx
• 00841742143538: DRACO ø4.3mm Cannnulated Headless Compression Screw, Partially Thread, Ti - (L)50mm, Torx
• 00841742143521: DRACO ø4.3mm Cannnulated Headless Compression Screw, Partially Thread, Ti - (L)48mm, Torx
• 00841742143514: DRACO ø4.3mm Cannnulated Headless Compression Screw, Partially Thread, Ti - (L)46mm, Torx
• 00841742143507: DRACO ø4.3mm Cannnulated Headless Compression Screw, Partially Thread, Ti - (L)44mm, Torx
• 00841742143491: DRACO ø4.3mm Cannnulated Headless Compression Screw, Partially Thread, Ti - (L)42mm, Torx
• 00841742143484: DRACO ø4.3mm Cannnulated Headless Compression Screw, Partially Thread, Ti - (L)40mm, Torx
• 00841742143477: DRACO ø4.3mm Cannnulated Headless Compression Screw, Partially Thread, Ti - (L)38mm, Torx
• 00841742143460: DRACO ø4.3mm Cannnulated Headless Compression Screw, Partially Thread, Ti - (L)36mm, Torx
• 00841742143453: DRACO ø4.3mm Cannnulated Headless Compression Screw, Partially Thread, Ti - (L)34mm, Torx
• 00841742143446: DRACO ø4.3mm Cannnulated Headless Compression Screw, Partially Thread, Ti - (L)32mm, Torx
• 00841742143439: DRACO ø4.3mm Cannnulated Headless Compression Screw, Partially Thread, Ti - (L)30mm, Torx
• 00841742143422: DRACO ø4.3mm Cannnulated Headless Compression Screw, Partially Thread, Ti - (L)28mm, Torx
• 00841742143415: DRACO ø4.3mm Cannnulated Headless Compression Screw, Partially Thread, Ti - (L)26mm, Torx
• 00841742143408: DRACO ø4.3mm Cannnulated Headless Compression Screw, Partially Thread, Ti - (L)24mm, Torx
• 00841742143392: DRACO ø3.0mm Cannnulated Headless Compression Screw, Partially Thread, Ti - (L)40mm, Torx
• 00841742143385: DRACO ø3.0mm Cannnulated Headless Compression Screw, Partially Thread, Ti - (L)35mm, Torx
• 00841742143378: DRACO ø3.0mm Cannnulated Headless Compression Screw, Partially Thread, Ti - (L)32mm, Torx
• 00841742143361: DRACO ø3.0mm Cannnulated Headless Compression Screw, Partially Thread, Ti - (L)30mm, Torx
• 00841742143354: DRACO ø3.0mm Cannnulated Headless Compression Screw, Partially Thread, Ti - (L)28mm, Torx
• 00841742143347: DRACO ø3.0mm Cannnulated Headless Compression Screw, Partially Thread, Ti - (L)26mm, Torx
• 00841742143330: DRACO ø3.0mm Cannnulated Headless Compression Screw, Partially Thread, Ti - (L)24mm, Torx
• 00841742143323: DRACO ø3.0mm Cannnulated Headless Compression Screw, Partially Thread, Ti - (L)22mm, Torx
• 00841742143316: DRACO ø3.0mm Cannnulated Headless Compression Screw, Partially Thread, Ti - (L)20mm, Torx
• 00841742143309: DRACO ø3.0mm Cannnulated Headless Compression Screw, Partially Thread, Ti - (L)18mm, Torx
• 00841742143293: DRACO ø3.0mm Cannnulated Headless Compression Screw, Partially Thread, Ti - (L)16mm, Torx
• 00841742143286: DRACO ø3.0mm Cannnulated Headless Compression Screw, Partially Thread, Ti - (L)14mm, Torx
• 00841742143279: DRACO ø3.0mm Cannnulated Headless Compression Screw, Partially Thread, Ti - (L)12mm, Torx
• 00841742143262: DRACO ø3.0mm Headed Cortical Screw, Full Thread, Ti - (L)40mm, Torx, Self-Drilling
• 00841742143255: DRACO ø3.0mm Headed Cortical Screw, Full Thread, Ti - (L)38mm, Torx, Self-Drilling
• 00841742143248: DRACO ø3.0mm Headed Cortical Screw, Full Thread, Ti - (L)36mm, Torx, Self-Drilling
• 00841742143231: DRACO ø3.0mm Headed Cortical Screw, Full Thread, Ti - (L)34mm, Torx, Self-Drilling
• 00841742143224: DRACO ø3.0mm Headed Cortical Screw, Full Thread, Ti - (L)32mm, Torx, Self-Drilling
• 00841742143217: DRACO ø3.0mm Headed Cortical Screw, Full Thread, Ti - (L)30mm, Torx, Self-Drilling
• 00841742143200: DRACO ø3.0mm Headed Cortical Screw, Full Thread, Ti - (L)28mm, Torx, Self-Drilling
• 00841742143194: DRACO ø3.0mm Headed Cortical Screw, Full Thread, Ti - (L)26mm, Torx, Self-Drilling
• 00841742143187: DRACO ø3.0mm Headed Cortical Screw, Full Thread, Ti - (L)24mm, Torx, Self-Drilling
• 00841742143170: DRACO ø3.0mm Headed Cortical Screw, Full Thread, Ti - (L)22mm, Torx, Self-Drilling
• 00841742143163: DRACO ø3.0mm Headed Cortical Screw, Full Thread, Ti - (L)20mm, Torx, Self-Drilling
• 00841742143156: DRACO ø3.0mm Headed Cortical Screw, Full Thread, Ti - (L)18mm, Torx, Self-Drilling
• 00841742143149: DRACO ø3.0mm Headed Cortical Screw, Full Thread, Ti - (L)16mm, Torx, Self-Drilling
• 00841742143132: DRACO ø3.0mm Headed Cortical Screw, Full Thread, Ti - (L)14mm, Torx, Self-Drilling
• 00841742143125: DRACO ø3.0mm Headed Cortical Screw, Full Thread, Ti - (L)12mm, Torx, Self-Drilling
• 00841742143118: DRACO ø3.0mm Cannnulated Headed Compression Screw, Partially Thread, Ti - (L)48mm, Torx
• 00841742143101: DRACO ø3.0mm Cannnulated Headed Compression Screw, Partially Thread, Ti - (L)46mm, Torx
• 00841742143095: DRACO ø3.0mm Cannnulated Headed Compression Screw, Partially Thread, Ti - (L)44mm, Torx