Paxeon Femoral Head

GUDID 08177570200221

Paxeon Head, Ceramic Size 40mm S

PAXEON RECONSTRUCTION LLC

Ceramic femoral head prosthesis

• Primary Device ID: 08177570200221
• NIH Device Record Key: 48715b87-e0ff-4f50-bac3-2ae729da031e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Paxeon Femoral Head
• Version Model Number: PR111-152-641
• Company DUNS: 080437990
• Company Name: PAXEON RECONSTRUCTION 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: 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 Identifiers

Device Issuing Agency	Device ID
GS1	08177570200221 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121297

FDA Product Code

• MEH: Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-09-09
• Device Publish Date: 2016-12-14

On-Brand Devices [Paxeon Femoral Head]

• 08177570200290: Paxeon Head 40mm, CoCr Size XL
• 08177570200283: Paxeon Head 40mm, CoCr Size L
• 08177570200276: Paxeon Head 40mm, CoCr Size M
• 08177570200269: Paxeon Head 40mm, CoCr Size S
• 08177570200108: Paxeon Head 36mm, CoCr Size XL
• 08177570200092: Paxeon Head 36mm, CoCr Size L
• 08177570200085: Paxeon Head 36mm, CoCr Size M
• 08177570200078: Paxeon Head 36mm, CoCr Size S
• 08177570200061: Paxeon Head 32mm, CoCr Size XL
• 08177570200054: Paxeon Head 32mm, CoCr Size L
• 08177570200047: Paxeon Head 32mm, CoCr Size M
• 08177570200030: Paxeon Head 32mm, CoCr Size S
• 08177570200023: Paxeon Head 28mm, CoCr Size L
• 08177570200016: Paxeon Head 28mm, CoCr Size M
• 08177570200009: Paxeon Head 28mm, CoCr Size S
• 08177570200252: Paxeon Head, Ceramic Size 40mm XL
• 08177570200245: Paxeon Head, Ceramic Size 40mm L
• 08177570200238: Paxeon Head, Ceramic Size 40mm M
• 08177570200221: Paxeon Head, Ceramic Size 40mm S
• 08177570200214: Paxeon Head, Ceramic Size 36mm XL
• 08177570200207: Paxeon Head, Ceramic Size 36mm L
• 08177570200191: Paxeon Head, Ceramic Size 36mm M
• 08177570200184: Paxeon Head, Ceramic Size 36mm S
• 08177570200177: Paxeon Head, Ceramic Size 32mm XL
• 08177570200160: Paxeon Head, Ceramic Size 32mm L
• 08177570200153: Paxeon Head, Ceramic Size 32mm M
• 08177570200146: Paxeon Head, Ceramic Size 32mm S
• 08177570200139: Paxeon Head, Ceramic Size 28mm L
• 08177570200122: Paxeon Head, Ceramic Size 28mm M
• 08177570200115: Paxeon Head, Ceramic Size 28mm S