Klassic HD® Hooded Acetabular Insert With E-Link® Poly, Klassic HD® Low Profile Acetabular Insert With E-Link® Poly
Hip Prosthesis, Semi-constrained, Cemented, Metal/polymer, + Additive, Porous, Uncemented
Total Joint Orthopedics, Inc.
The following data is part of a premarket notification filed by Total Joint Orthopedics, Inc. with the FDA for Klassic Hd® Hooded Acetabular Insert With E-link® Poly, Klassic Hd® Low Profile Acetabular Insert With E-link® Poly.
Pre-market Notification Details
| Device ID | K173104 |
| 510k Number | K173104 |
| Device Name: | Klassic HD® Hooded Acetabular Insert With E-Link® Poly, Klassic HD® Low Profile 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-29 |
| Decision Date | 2017-10-27 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814703013928 | K173104 | 000 |
| 00814703013751 | K173104 | 000 |
| 00814703013744 | K173104 | 000 |
| 00814703013737 | K173104 | 000 |
| 00814703013720 | K173104 | 000 |
| 00814703013713 | K173104 | 000 |
| 00814703013706 | K173104 | 000 |
| 00814703013690 | K173104 | 000 |
| 00814703013683 | K173104 | 000 |
| 00814703013676 | K173104 | 000 |
| 00814703013669 | K173104 | 000 |
| 00814703013652 | K173104 | 000 |
| 00814703013645 | K173104 | 000 |
| 00814703013638 | K173104 | 000 |
| 00814703013621 | K173104 | 000 |
| 00814703013768 | K173104 | 000 |
| 00814703013775 | K173104 | 000 |
| 00814703013911 | K173104 | 000 |
| 00814703013904 | K173104 | 000 |
| 00814703013898 | K173104 | 000 |
| 00814703013881 | K173104 | 000 |
| 00814703013874 | K173104 | 000 |
| 00814703013867 | K173104 | 000 |
| 00814703013850 | K173104 | 000 |
| 00814703013843 | K173104 | 000 |
| 00814703013836 | K173104 | 000 |
| 00814703013829 | K173104 | 000 |
| 00814703013812 | K173104 | 000 |
| 00814703013805 | K173104 | 000 |
| 00814703013799 | K173104 | 000 |
| 00814703013782 | K173104 | 000 |
| 00814703013614 | K173104 | 000 |
Trademark Results [Klassic HD]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 KLASSIC HD 77922134 3865858 Live/Registered |
JOINT DEVELOPMENT, LLC 2010-01-28 |
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