Howmedica Femoral Component Hip Sys 6259
FDA 510(k) K851566 · Howmedica Corp.
510(k) numberK851566
Submission
- Device name
- Howmedica Femoral Component Hip Sys 6259
- Applicant
- Howmedica Corp.
Rutherford, NJ, US - Received
- April 16, 1985
- Decision date
- July 30, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JDG – Prosthesis, Hip, Femoral Component, Cemented, Metal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3360
- Specialty
- Orthopedic
- Implant
- Yes
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|---|---|---|---|
| K212431 | Biomet Answer/Impact/Integral Distal Centralizer/Centering SleeveJDG · Traditional | Biomet, Inc. | 02/07/2022SE |
| K193546 | Distal CentralizersJDG · Traditional | Biomet, Inc. | 09/25/2020SE |
| K173499 | Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsJDG · Traditional | Stryker Orthopaedics | 03/19/2018SE |
| K001984 | Progeny Forged Cocr Cemented Femoral ComponentJDG · Traditional | Stelkast Company | 09/27/2000SE |
| K992234 | The Taper-Fit Total Hip SystemJDG · Traditional | Corin USA | 11/10/1999SE |
| K962002 | Aura Hip System Calcar Replacement Femoral StemJDG · Traditional | Exactech, Inc. | 08/08/1996SE |
| K955171 | Nexlock Femoral StemJDG · Traditional | Nexmed, Inc. | 02/09/1996SE |
| K953653 | Lubinus SP II Hip SystemJDG · Traditional | Turnkey Intergration USA, Inc. | 11/06/1995SE |
| K953067 | Hip Fracture Stem Fenestration PlugJDG · Traditional | Howmedica Corp. | 08/21/1995SE |
| K945783 | Orthomet Titanium Hybrid Femoral StemJDG · Traditional | Orthomet, Inc. | 05/30/1995SE |
More from Orthomet, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K984251 | Xia Spine SystemKWQ · Traditional | 02/24/1999SE |
| K984202 | Howmedica Humeral Intercalary SystemHSD · Traditional | 02/05/1999SE |
| K984305 | Zeta Multizone Locking Nail SystemHSB · Traditional | 02/01/1999SE |
| K983885 | Burr Hole Covers, Craniomaxillofacial PlatesJEY · Traditional | 01/29/1999SE |
| K983528 | Micro Dynamic MeshJEY · Traditional | 12/23/1998SE |
| K983404 | Type 3 Femoral ComponentsLZO · Traditional | 12/22/1998SE |
| K980926 | Duration II Acetabular Components-Ethylene Oxide SterilizationJDI · Traditional | 12/16/1998SE |
| K980925 | Duration II Tibial Inserts-Ethylene Oxide SterilizationJWH · Traditional | 12/16/1998SE |
| K980632 | Duration II Tibial Inserts - Gas Plasma SterilizationJWH · Traditional | 12/11/1998SE |
| K980626 | Duration II Acetabular Components-Gas Plasma SterilizationJDI · Traditional | 12/11/1998SE |
Questions and answers
When was Howmedica Femoral Component Hip Sys 6259 cleared by the FDA?
Howmedica Femoral Component Hip Sys 6259 (K851566) received a 510(k) decision of Substantially Equivalent on July 30, 1985, 105 days after the submission was received.
What is the product code of K851566?
The FDA product code is JDG – Prosthesis, Hip, Femoral Component, Cemented, Metal, a Class II (moderate risk) device regulated under 21 CFR 888.3360.