Paxeon Femoral Head

GUDID 08177570200160

Paxeon Head, Ceramic Size 32mm L

PAXEON RECONSTRUCTION LLC

Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis

• Primary Device ID: 08177570200160
• NIH Device Record Key: 005da2fe-e21b-4ee2-9f00-38e48b7e5863
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Paxeon Femoral Head
• Version Model Number: PR111-152-623
• 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	08177570200160 [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