The following data is part of a premarket notification filed by Total Joint Orthopedics, Inc. with the FDA for Klassic Hd Hip System.
| Device ID | K151440 |
| 510k Number | K151440 |
| Device Name: | Klassic HD Hip System |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | TOTAL JOINT ORTHOPEDICS, INC. 1567 E. STRATFORD AVENUE Salt Lake City, UT 84106 |
| Contact | Chris Weaber |
| Correspondent | Chris Weaber TOTAL JOINT ORTHOPEDICS, INC. 1567 E. STRATFORD AVENUE Salt Lake City, UT 84106 |
| Product Code | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-29 |
| Decision Date | 2015-09-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814703012372 | K151440 | 000 |
| 00814703012211 | K151440 | 000 |
| 00814703012228 | K151440 | 000 |
| 00814703012235 | K151440 | 000 |
| 00814703012242 | K151440 | 000 |
| 00814703012259 | K151440 | 000 |
| 00814703012266 | K151440 | 000 |
| 00814703012273 | K151440 | 000 |
| 00814703012280 | K151440 | 000 |
| 00814703012297 | K151440 | 000 |
| 00814703012303 | K151440 | 000 |
| 00814703012310 | K151440 | 000 |
| 00814703012327 | K151440 | 000 |
| 00814703012334 | K151440 | 000 |
| 00814703012341 | K151440 | 000 |
| 00814703012358 | K151440 | 000 |
| 00814703012365 | K151440 | 000 |
| 00814703012204 | K151440 | 000 |