Scorpio 82-2-0515

GUDID 04546540400628

Tibial Bearing Insert

Howmedica Osteonics Corp.

Tibial insert

• Primary Device ID: 04546540400628
• NIH Device Record Key: d73b8209-ef13-4456-a2b8-f84603dec598
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Scorpio
• Version Model Number: 82-2-0515
• Catalog Number: 82-2-0515
• Company DUNS: 058311945
• Company Name: Howmedica Osteonics Corp.
• 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: true
• OTC Over-The-Counter: false

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	04546540400628 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042343

FDA Product Code

• JWH: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

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: 2017-06-19

On-Brand Devices [Scorpio]

• 07613327102222: Posterior Stabilized Tibial Insert
• 07613327102215: Posterior Stabilized Tibial Insert
• 07613327102208: Posterior Stabilized Tibial Insert
• 07613327102192: Posterior Stabilized Tibial Insert
• 07613327102185: Posterior Stabilized Tibial Insert
• 07613327102178: Posterior Stabilized Tibial Insert
• 07613327102161: Posterior Stabilized Tibial Insert
• 07613327102154: Posterior Stabilized Tibial Insert
• 07613327102147: Posterior Stabilized Tibial Insert
• 07613327102123: Posterior Stabilized Tibial Insert
• 07613327102116: Posterior Stabilized Tibial Insert
• 07613327102093: Posterior Stabilized Tibial Insert
• 07613327102086: Posterior Stabilized Tibial Insert
• 07613327102079: Posterior Stabilized Tibial Insert
• 07613327102062: Posterior Stabilized Tibial Insert
• 07613327102024: Posterior Stabilized Tibial Insert
• 07613327050912: Posterior Stabilized Tibial Insert
• 07613327050332: Resurfacing Patella Component
• 07613327050301: Resurfacing Patella Component
• 07613327050295: Resurfacing Patella Component
• 07613327050288: Resurfacing Patella Component
• 07613327044607: Cruciate Retaining Tibial Insert
• 07613327044591: Cruciate Retaining Tibial Insert
• 07613327044584: Cruciate Retaining Tibial Insert
• 07613327044577: Cruciate Retaining Tibial Insert
• 07613327044560: Cruciate Retaining Tibial Insert
• 07613327044553: Cruciate Retaining Tibial Insert
• 07613327044546: Cruciate Retaining Tibial Insert
• 07613327044539: Cruciate Retaining Tibial Insert
• 07613327044522: Cruciate Retaining Tibial Insert
• 07613327044515: Cruciate Retaining Tibial Insert
• 07613327044508: Cruciate Retaining Tibial Insert
• 07613327044492: Cruciate Retaining Tibial Insert
• 07613327044485: Cruciate Retaining Tibial Insert
• 07613327044478: Cruciate Retaining Tibial Insert
• 07613327044461: Cruciate Retaining Tibial Insert
• 07613327044454: Cruciate Retaining Tibial Insert
• 07613327044447: Cruciate Retaining Tibial Insert
• 07613327044430: Cruciate Retaining Tibial Insert
• 07613327044423: Cruciate Retaining Tibial Insert
• 07613327044416: Cruciate Retaining Tibial Insert
• 07613327044409: Cruciate Retaining Tibial Insert
• 07613327044393: Cruciate Retaining Tibial Insert
• 07613327044386: Cruciate Retaining Tibial Insert
• 07613327044379: Cruciate Retaining Tibial Insert
• 07613327044362: Cruciate Retaining Tibial Insert
• 07613327044355: Cruciate Retaining Tibial Insert
• 07613327044348: Cruciate Retaining Tibial Insert
• 07613327044331: Cruciate Retaining Tibial Insert
• 07613327044324: Cruciate Retaining Tibial Insert