The following data is part of a premarket notification filed by Pipeline Biomedical Products, Llc with the FDA for Pbp Total Hip System.
Device ID | K122158 |
510k Number | K122158 |
Device Name: | PBP TOTAL HIP SYSTEM |
Classification | Hip Prosthesis, Semi-constrained, Cemented, Metal/polymer, + Additive, Porous, Uncemented |
Applicant | PIPELINE BIOMEDICAL PRODUCTS, LLC 901 KING STREET SUITE 200 Alexandria, VA 22314 |
Contact | Terry Powell |
Correspondent | Terry Powell PIPELINE BIOMEDICAL PRODUCTS, LLC 901 KING STREET SUITE 200 Alexandria, VA 22314 |
Product Code | OQG |
Subsequent Product Code | JDI |
Subsequent Product Code | LPH |
Subsequent Product Code | LZO |
Subsequent Product Code | MEH |
Subsequent Product Code | OQH |
Subsequent Product Code | OQI |
CFR Regulation Number | 888.3358 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-07-20 |
Decision Date | 2012-12-11 |
Summary: | summary |