The following data is part of a premarket notification filed by Total Joint Orthopedics, Inc. with the FDA for Klassic Hd Acetabular Insert With E-link Poly.
| Device ID | K141972 |
| 510k Number | K141972 |
| Device Name: | KLASSIC HD ACETABULAR INSERT WITH E-LINK POLY |
| Classification | Hip Prosthesis, Semi-constrained, Cemented, Metal/polymer, + Additive, 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 | OQG |
| Subsequent 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 | 2014-07-21 |
| Decision Date | 2014-10-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814703011818 | K141972 | 000 |
| 00814703011672 | K141972 | 000 |
| 00814703011689 | K141972 | 000 |
| 00814703011696 | K141972 | 000 |
| 00814703011702 | K141972 | 000 |
| 00814703011719 | K141972 | 000 |
| 00814703011726 | K141972 | 000 |
| 00814703011733 | K141972 | 000 |
| 00814703011740 | K141972 | 000 |
| 00814703011757 | K141972 | 000 |
| 00814703011764 | K141972 | 000 |
| 00814703011771 | K141972 | 000 |
| 00814703011788 | K141972 | 000 |
| 00814703011795 | K141972 | 000 |
| 00814703011801 | K141972 | 000 |
| 00814703011665 | K141972 | 000 |