FDA Product Code
FDA Product Code OQG — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3358
510(k) Clearances — 20 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K202705 | Prime and DYNASTY® Additive Manufacturing Shells | Microport Orthopedics, Inc. | 2021-08-20 | Traditional | PDF ↗ |
| K203472 | KMTI Hip Replacement System | Kyocera Medical Technologies, Inc. | 2021-04-02 | Special | PDF ↗ |
| K201660 | KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System | Kyocera Medical Technologies, Inc. | 2020-07-16 | Special | PDF ↗ |
| K200328 | Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System | Kyocera Medical Technologies, Inc. | 2020-03-11 | Special | PDF ↗ |
| K172651 | FMP Extended Liners | Encore Medical L.P. | 2017-12-13 | Traditional | PDF ↗ |
| K171543 | Renovis Surgical Hip Replacement System | Renovis Surgical Technologies | 2017-11-16 | Traditional | PDF ↗ |
| K173104 | Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile Acetabular Insert with E-Link® Poly | Total Joint Orthopedics, Inc. | 2017-10-27 | Special | PDF ↗ |
| K143647 | Renovis Surgical Hip Replacement System | Renovis Surgical Technologies, Inc. | 2015-05-11 | Traditional | PDF ↗ |
| K140130 | X-ALT HIGHLY CROSS LINKED ACETABULAR LINERS WITH VITAMIN E, NEUTRAL, 10 DEGREE HOODED, 20 DEGREE HOODED | Encore Medical L.P. | 2014-11-06 | Traditional | PDF ↗ |
| K141972 | KLASSIC HD ACETABULAR INSERT WITH E-LINK POLY | Total Joint Orthopedics, Inc. | 2014-10-09 | Traditional | PDF ↗ |
| K140701 | NOVOHIP BIPOLAR HEAD/NOVOHIP VITAMIN E LINER/ BONE SCREWS/ HOLE PLUG | Novosource, Inc. | 2014-06-27 | Traditional | PDF ↗ |
| K130652 | VITALITE E CROSS-LINKED POLYETHYLENE ACETABULAR INSERT | Consensus Orthopedics, Inc. | 2013-12-17 | Traditional | PDF ↗ |
| K122783 | PLASMAFIT ACETABULAR CUP AND VITELENE INSERT | Aesculap Implant System, Inc. | 2013-10-30 | Traditional | PDF ↗ |
| K130365 | X-ALT HIGHLY CROSS LINKED VE ACETABULAR LINER | Encore Medical L.P. | 2013-09-23 | Traditional | PDF ↗ |
| K122158 | PBP TOTAL HIP SYSTEM | Pipeline Biomedical Products, LLC | 2012-12-11 | Traditional | PDF ↗ |
| K122773 | CROSS-OVER ACETABULAR SHELL & LINER | Stelkast Company | 2012-10-09 | Special | PDF ↗ |
| K112897 | RENOVIS SURGICAL HIP JOINT REPLACEMENT PROSTHESIS | Renovis Surgical Technologies, LLC | 2012-06-13 | Traditional | PDF ↗ |
| K120370 | VIVACIT-E VITAMIN E HIGHLY CROSSLINKED POLYETHYLENE LINERS | Zimmer, Inc. | 2012-06-04 | Traditional | PDF ↗ |
| K112802 | PIPELINE TOTAL HIP SYSTEM | Pipeline Orthopedics | 2012-03-09 | Traditional | PDF ↗ |
| K094035 | EXP ACETABULAR LINER, MODELS SC3342 NON-HOODED 28MM, SC3343 HOODED 28MM | Stelkast Company | 2011-03-24 | Traditional | PDF ↗ |
Product code OQG · Class II · Orthopedic. Data: openFDA.