Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K180929
Klassic HD® Hip System · Total Joint Orthopedics, Inc. · decided 2018-05-09 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| Klassic HD Hooded Acetabular Insert with XLPE Poly | 3508.58.032 | TOTAL JOINT ORTHOPEDICS, INC. | OQG | 00814703015342 |
| Klassic HD Low Profile Acetabular Insert with E-Link Poly | 3509.46.028 | TOTAL JOINT ORTHOPEDICS, INC. | OQG | 00814703015199 |
| Klassic HD Acetabular Cup with Ti-Coat | 3400.44.000 | TOTAL JOINT ORTHOPEDICS, INC. | LPH LWJ MBL | 00814703014963 |
| Klassic HD Low Profile Acetabular Insert with XLPE Poly | 3510.56.036 | TOTAL JOINT ORTHOPEDICS, INC. | OQG | 00814703015601 |
| 22mm BIOLOX delta Ceramic Femoral Head, 12/14 taper | 3203.22.000 | TOTAL JOINT ORTHOPEDICS, INC. | LPH LZO MBL | 00814703014895 |
| Klassic HD Hooded Acetabular Insert with E-Link Poly | 3507.44.022 | TOTAL JOINT ORTHOPEDICS, INC. | OQG | 00814703015106 |
| Klassic HD Low Profile Acetabular Insert with XLPE Poly | 3510.58.036 | TOTAL JOINT ORTHOPEDICS, INC. | OQG | 00814703015618 |
| Klassic HD Low Profile Acetabular Insert with XLPE Poly | 3510.60.032 | TOTAL JOINT ORTHOPEDICS, INC. | OQG | 00814703015557 |
| Klassic HD Hooded Acetabular Insert with XLPE Poly | 3508.46.022 | TOTAL JOINT ORTHOPEDICS, INC. | OQG | 00814703015267 |
| Klassic HD Acetabular Insert with E-Link Poly | 3502.44.022 | TOTAL JOINT ORTHOPEDICS, INC. | LPH MBL OQG | 00814703014987 |
| Klassic HD Hooded Acetabular Insert with XLPE Poly | 3508.58.036 | TOTAL JOINT ORTHOPEDICS, INC. | OQG | 00814703015410 |
| Klassic HD Low Profile Acetabular Insert with XLPE Poly | 3510.44.022 | TOTAL JOINT ORTHOPEDICS, INC. | OQG | 00814703015458 |
| Klassic HD Low Profile Acetabular Insert with XLPE Poly | 3510.62.036 | TOTAL JOINT ORTHOPEDICS, INC. | OQG | 00814703015632 |
| Klassic HD Low Profile Acetabular Insert with XLPE Poly | 3510.64.032 | TOTAL JOINT ORTHOPEDICS, INC. | OQG | 00814703015571 |
| Klassic HD Low Profile Acetabular Insert with XLPE Poly | 3510.52.036 | TOTAL JOINT ORTHOPEDICS, INC. | OQG | 00814703015588 |
| Klassic HD Hooded Acetabular Insert with XLPE Poly | 3508.44.022 | TOTAL JOINT ORTHOPEDICS, INC. | OQG | 00814703015250 |
| Klassic HD Hooded Acetabular Insert with XLPE Poly | 3508.56.036 | TOTAL JOINT ORTHOPEDICS, INC. | OQG | 00814703015403 |
| Klassic HD Low Profile Acetabular Insert with XLPE Poly | 3510.64.036 | TOTAL JOINT ORTHOPEDICS, INC. | OQG | 00814703015649 |
| Klassic HD Hooded Acetabular Insert with XLPE Poly | 3508.64.032 | TOTAL JOINT ORTHOPEDICS, INC. | OQG | 00814703015373 |
| 28mm BIOLOX delta Ceramic Femoral Head, 12/14 taper | 3203.28.000 | TOTAL JOINT ORTHOPEDICS, INC. | LPH LZO MBL | 00814703014932 |
| Klassic HD Acetabular Insert with E-Link Poly | 3502.44.028 | TOTAL JOINT ORTHOPEDICS, INC. | LPH MBL OQG | 00814703015007 |
| Klassic HD Acetabular Insert with XLPE | 3503.46.022 | TOTAL JOINT ORTHOPEDICS, INC. | LPH LWJ MBL | 00814703015052 |
| Klassic HD Low Profile Acetabular Insert with XLPE Poly | 3510.54.032 | TOTAL JOINT ORTHOPEDICS, INC. | OQG | 00814703015526 |
| Klassic HD Acetabular Cup with Ti-Coat | 3400.46.000 | TOTAL JOINT ORTHOPEDICS, INC. | LPH LWJ MBL | 00814703014970 |
| Klassic HD Low Profile Acetabular Insert with XLPE Poly | 3510.46.028 | TOTAL JOINT ORTHOPEDICS, INC. | OQG | 00814703015489 |