Biolign Rotoloc RL200361

GUDID 06009708424532

Rotoloc Cervical Plate 36mm LV1

ELITE SURGICAL SUPPLIES (PTY) LTD

Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 06009708424532
• NIH Device Record Key: 8bbe5bd7-b78d-4a92-a835-55a81691b80d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Biolign Rotoloc
• Version Model Number: RL200361
• Catalog Number: RL200361
• Company DUNS: 568359710
• Company Name: ELITE SURGICAL SUPPLIES (PTY) LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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: true
• OTC Over-The-Counter: false

Device Dimensions

• Length: 36 Millimeter
• Length: 36 Millimeter
• Length: 36 Millimeter
• Length: 36 Millimeter
• Length: 36 Millimeter
• Length: 36 Millimeter
• Length: 36 Millimeter
• Length: 36 Millimeter
• Length: 36 Millimeter
• Length: 36 Millimeter
• Length: 36 Millimeter
• Length: 36 Millimeter
• Length: 36 Millimeter
• Length: 36 Millimeter
• Length: 36 Millimeter
• Length: 36 Millimeter
• Length: 36 Millimeter
• Length: 36 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	06009708424532 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200523

FDA Product Code

• KWQ: Appliance, Fixation, Spinal Intervertebral Body

Sterilization

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

[06009708424532]

Moist Heat or Steam Sterilization

[06009708424532]

Moist Heat or Steam Sterilization

[06009708424532]

Moist Heat or Steam Sterilization

[06009708424532]

Moist Heat or Steam Sterilization

[06009708424532]

Moist Heat or Steam Sterilization

[06009708424532]

Moist Heat or Steam Sterilization

[06009708424532]

Moist Heat or Steam Sterilization

[06009708424532]

Moist Heat or Steam Sterilization

[06009708424532]

Moist Heat or Steam Sterilization

[06009708424532]

Moist Heat or Steam Sterilization

[06009708424532]

Moist Heat or Steam Sterilization

[06009708424532]

Moist Heat or Steam Sterilization

[06009708424532]

Moist Heat or Steam Sterilization

[06009708424532]

Moist Heat or Steam Sterilization

[06009708424532]

Moist Heat or Steam Sterilization

[06009708424532]

Moist Heat or Steam Sterilization

[06009708424532]

Moist Heat or Steam Sterilization

[06009708424532]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-07-26
• Device Publish Date: 2021-07-16

On-Brand Devices [Biolign Rotoloc]

• 06009708420442: Rotoloc Cervical Plate 20mm Lvl1
• 06009708424471: Rotoloc Cervical Plate 24mm LV1
• 06009708420459: Rotoloc Cervical Plate 22mm LV1
• 06009708424839: Rotoloc Cervical Plate 68mm LV4
• 06009708424822: Rotoloc Cervical Plate 66mm LV4
• 06009708424815: Rotoloc Cervical Plate 64mm LV4
• 06009708424808: Rotoloc Cervical Plate 62mm LV4
• 06009708424778: Rotoloc Cervical Plate 70mm LV3
• 06009708424761: Rotoloc Cervical Plate 68mm LV3
• 06009708424754: Rotoloc Cervical Plate 66mm LV3
• 06009708424747: Rotoloc Cervical Plate 64mm LV3
• 06009708424730: Rotoloc Cervical Plate 62mm LV3
• 06009708424723: Rotoloc Cervical Plate 60mm LV3
• 06009708424716: Rotoloc Cervical Plate 58mm LV3
• 06009708424709: Rotoloc Cervical Plate 56mm LV3
• 06009708424693: Rotoloc Cervical Plate 54mm LV3
• 06009708424686: Rotoloc Cervical Plate 52mm LV3
• 06009708424679: Rotoloc Cervical Plate 50mm LV3
• 06009708424662: Rotoloc Cervical Plate 48mm LV3
• 06009708424655: Rotoloc Cervical Plate 54mm LV2
• 06009708424648: Rotoloc Cervical Plate 52mm LV2
• 06009708424631: Rotoloc Cervical Plate 50mm LV2
• 06009708424624: Rotoloc Cervical Plate 48mm LV2
• 06009708424617: Rotoloc Cervical Plate 46mm LV2
• 06009708424600: Rotoloc Cervical Plate 44mm LV2
• 06009708424594: Rotoloc Cervical Plate 42mm LV2
• 06009708424587: Rotoloc Cervical Plate 40mm LV2
• 06009708424570: Rotoloc Cervical Plate 38mm LV2
• 06009708424563: Rotoloc Cervical Plate 36mm LV2
• 06009708424556: Rotoloc Cervical Plate 34mm LV2
• 06009708424549: Rotoloc Cervical Plate 32mm LV12
• 06009708424532: Rotoloc Cervical Plate 36mm LV1
• 06009708424525: Rotoloc Cervical Plate 34mm LV1
• 06009708424518: Rotoloc Cervical Plate 32mm LV1
• 06009708424501: Rotoloc Cervical Plate 30mm LV1
• 06009708424495: Rotoloc Cervical Plate 28mm LV1
• 06009708424488: Rotoloc Cervical Plate 26mm LV1
• 06009708424846: Rotoloc Cervical Plate 70mm LV4
• 06009708424785: Rotoloc Cervical Plate 72mm LV3
• 06009708424907: Rotoloc Cervical Plate 82mm LV4
• 06009708424891: Rotoloc Cervical Plate 80mm LV4
• 06009708424884: Rotoloc Cervical Plate 78mm LV4
• 06009708424877: Rotoloc Cervical Plate 76mm LV4
• 06009708424860: Rotoloc Cervical Plate 74mm LV4
• 06009708424853: Rotoloc Cervical Plate 72mm LV4
• 06009708424792: Rotoloc Cervical Plate 74mm LV3
• 06009708425713: Roto-Loc Variable Angled Cervical Screw 4.6 x 18mm
• 06009708425706: Roto-Loc Variable Angled Cervical Screw 4.6 x 16mm
• 06009708425690: Roto-Loc Variable Angled Cervical Screw 4.6 x 14mm
• 06009708425683: Roto-Loc Variable Angled Cervical Screw 4.6 x 12mm