Femoral Head

GUDID 09348215053635

SIGNATURE ORTHOPAEDICS PTY LTD

Ceramic femoral head prosthesis

• Primary Device ID: 09348215053635
• NIH Device Record Key: 7652ac28-d5c6-4e96-bd35-12316d258406
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Femoral Head
• Version Model Number: 400-03-324
• Company DUNS: 751993028
• Company Name: SIGNATURE ORTHOPAEDICS PTY LTD
• 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	09348215053635 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121297

FDA Product Code

• LZO: Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

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: 2022-09-28
• Device Publish Date: 2022-09-20

On-Brand Devices [Femoral Head]

• 09348215053710: 400-03-404
• 09348215053703: 400-03-403
• 09348215053697: 400-03-402
• 09348215053680: 400-03-401
• 09348215053673: 400-03-364
• 09348215053666: 400-03-363
• 09348215053659: 400-03-362
• 09348215053642: 400-03-361
• 09348215053635: 400-03-324
• 09348215053628: 400-03-323
• 09348215053611: 400-03-322
• 09348215053604: 400-03-321
• 09348215053598: 400-03-283
• 09348215053581: 400-03-282
• 09348215053574: 400-03-281
• 09348215053567: D111-152-044
• 09348215053550: D111-152-043
• 09348215053543: D111-152-042
• 09348215053536: D111-152-041
• 09348215053529: D111-152-034
• 09348215053512: D111-152-033
• 09348215053505: D111-152-032
• 09348215053499: D111-152-031
• 09348215053482: D111-152-024
• 09348215053475: D111-152-023
• 09348215053468: D111-152-022
• 09348215053451: D111-152-021
• 09348215053444: D111-152-013
• 09348215053437: D111-152-012
• 09348215053420: D111-152-011
• 09348215112523: 01-045-01-2204
• 09348215112516: 01-045-01-2200
• 09348215112509: 01-045-01-2294
• 09348215112493: 01-045-01-2804
• 09348215112486: 01-045-01-2800
• 09348215112479: 01-045-01-2894