AMERICANA HIP PROTHESIS
FDA 510(k) clearance K922682 · decided 1993-03-16
Clearance details
- K-number
- K922682
- Device name
- AMERICANA HIP PROTHESIS
- Applicant
- Osteo Technology, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-06-04
- Decision date
- 1993-03-16
- Days to decision
- 285 days
- Clearance type
- Traditional
- Product code
- JDG
- Device class
- 2
- Regulation number
- 888.3360
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Timonium, MD, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Osteo Technology
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeve (K212431) | Biomet, Inc. | 2022-02-07 |
| Distal Centralizers (K193546) | Biomet, Inc. | 2020-09-25 |
| Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads (K173499) | Stryker Orthopaedics | 2018-03-19 |
| PROGENY FORGED COCR CEMENTED FEMORAL COMPONENT (K001984) | Stelkast Company | 2000-09-27 |
| THE TAPER-FIT TOTAL HIP SYSTEM (K992234) | Corin USA | 1999-11-10 |
| AURA HIP SYSTEM CALCAR REPLACEMENT FEMORAL STEM (K962002) | Exactech, Inc. | 1996-08-08 |
| NEXLOCK FEMORAL STEM (K955171) | Nexmed, Inc. | 1996-02-09 |
| LUBINUS SP II HIP SYSTEM (K953653) | Turnkey Intergration USA, Inc. | 1995-11-06 |
| HIP FRACTURE STEM FENESTRATION PLUG (K953067) | Howmedica Corp. | 1995-08-21 |
| ORTHOMET TITANIUM HYBRID FEMORAL STEM (K945783) | Orthomet, Inc. | 1995-05-30 |
| PROFORM CEMENTED FEMORAL COMPONENT (K951083) | Stelkast Company | 1995-05-22 |
| INTEGRAL CO-CR FEMORAL COMPONENT (K942479) | Biomet, Inc. | 1994-09-20 |
Recalls involving this device
No recalls on record reference this clearance.