StageOne Select 431194

GUDID 00887868551659

Biomet Orthopedics, LLC

Orthopaedic cement spacer mould

• Primary Device ID: 00887868551659
• NIH Device Record Key: e45d7b5f-1106-40b2-b223-2e136258bcc7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: StageOne Select
• Version Model Number: 431194
• Catalog Number: 431194
• Company DUNS: 129278169
• Company Name: Biomet Orthopedics, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: true
• 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 Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887868551659 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080979

FDA Product Code

• KWL: Prosthesis, hip, hemi-, femoral, metal

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-03-25
• Device Publish Date: 2026-03-17

On-Brand Devices [StageOne Select]

• 00880304521995: 431190
• 00880304521254: 431183
• 00880304521247: 431192
• 00880304521230: 431191
• 00880304521179: 431193
• 00880304521162: 431199
• 00880304521155: 431194
• 00880304521148: 431197
• 00880304521131: 431198
• 00880304521124: 431195
• 00880304521117: 431196
• 00880304521100: 431181
• 00880304521094: 431188
• 00880304521087: 431186
• 00880304521070: 431187
• 00880304521063: 431185
• 00880304521056: 431184
• 00880304521032: 431182
• 00887868551703: 431199
• 00887868551697: 431198
• 00887868551680: 431197
• 00887868551673: 431196
• 00887868551666: 431195
• 00887868551659: 431194
• 00887868551642: 431193
• 00887868551635: 431192
• 00887868551628: 431191
• 00887868551611: 431190