The following data is part of a premarket notification filed by Pipeline Orthopedics with the FDA for Pipeline Total Hip System (line Extension).
| Device ID | K130353 |
| 510k Number | K130353 |
| Device Name: | PIPELINE TOTAL HIP SYSTEM (LINE EXTENSION) |
| 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 |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-12 |
| Decision Date | 2013-07-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00848486010089 | K130353 | 000 |
| 00848486010072 | K130353 | 000 |