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 |