PIPELINE TOTAL HIP SYSTEM

Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented

The following data is part of a premarket notification filed by Pipeline Orthopedics with the FDA for Pipeline Total Hip System.

Device ID	K131237
510k Number	K131237
Device Name:	PIPELINE TOTAL HIP SYSTEM
Classification	Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Applicant	PIPELINE ORTHOPEDICS 901 KING STREET, SUITE 200 Alexandria, VA 22314
Contact	Terry Powell
Correspondent	Terry Powell PIPELINE ORTHOPEDICS 901 KING STREET, SUITE 200 Alexandria, VA 22314
Product Code	LPH
Subsequent Product Code	JDI
Subsequent Product Code	LZO
Subsequent Product Code	MEH
Subsequent Product Code	OQG
Subsequent Product Code	OQH
Subsequent Product Code	OQI
CFR Regulation Number	888.3358 [🔎]
Decision	Substantially Equivalent (SESE)
Type	Special
3rd Party Reviewed	No
Combination Product	No
Date Received	2013-05-01
Decision Date	2013-06-13
Summary:	summary