The following data is part of a premarket notification filed by Total Joint Orthopedics, Inc. with the FDA for Klassic Hd Hip System, Offset Femoral Stem, Non-porous / Porous.
| Device ID | K133832 |
| 510k Number | K133832 |
| Device Name: | KLASSIC HD HIP SYSTEM, OFFSET FEMORAL STEM, NON-POROUS / POROUS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | TOTAL JOINT ORTHOPEDICS, INC. 1567 E. Stratford Avenue Salt Lake City, UT 84106 |
| Contact | Ben Casey |
| Correspondent | Ben Casey TOTAL JOINT ORTHOPEDICS, INC. 1567 E. Stratford Avenue Salt Lake City, UT 84106 |
| Product Code | LPH |
| Subsequent Product Code | LWJ |
| Subsequent Product Code | MBL |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-17 |
| Decision Date | 2014-03-13 |
| Summary: | summary |