The following data is part of a premarket notification filed by Joint Medical Products Corp. with the FDA for Arthopor I & Ii Acetabular Cup/arthopor Ii Oblong Acetabular Cup.
Device ID | K955511 |
510k Number | K955511 |
Device Name: | ARTHOPOR I & II ACETABULAR CUP/ARTHOPOR II OBLONG ACETABULAR CUP |
Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
Applicant | JOINT MEDICAL PRODUCTS CORP. 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
Contact | John D Ferros |
Correspondent | John D Ferros JOINT MEDICAL PRODUCTS CORP. 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
Product Code | LPH |
CFR Regulation Number | 888.3358 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-12-04 |
Decision Date | 1996-02-26 |