FDA Import Refusal 799-5531701-9/11/1 — Signature Orthopedics Pty Limited

Signature Orthopedics Pty Limited — FEI 3008262872

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