FDA Import Refusal 799-5531701-9/11/1 — Signature Orthopedics Pty Limited
The FDA refused shipment 799-5531701-9/11/1 from Signature Orthopedics Pty Limited (Australia) on Mar 10, 2020. The refused product falls under Devices — PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALCIUM-PHOSPHATE. Cited charges: 118,341,508 This firm has 5 or more other import refusals on record.
Refusal Details
- Date
- Mar 10, 2020
- Country
- Australia
- Product Category
- Devices
- Product Code
- 87MEH PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALCIUM-PHOSPHATE
- Charges
- 118,341,508