The following data is part of a premarket notification filed by Pipeline Biotechnology with the FDA for Pipeline Total Hip System (line Extension).
| Device ID | K132626 |
| 510k Number | K132626 |
| Device Name: | PIPELINE TOTAL HIP SYSTEM (LINE EXTENSION) |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | Pipeline Biotechnology 575 EIGHTH AVE, SUITE 1212 New York, NY 10018 |
| Contact | Terry Powell |
| Correspondent | Terry Powell Pipeline Biotechnology 575 EIGHTH AVE, SUITE 1212 New York, NY 10018 |
| 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 | 2013-08-22 |
| Decision Date | 2013-09-19 |
| Summary: | summary |