Charnley Congenital Hip Femur (85-3060)
FDA 510(k) K761002 · Codman & Shurtleff, Inc.
510(k) numberK761002
Submission
- Device name
- Charnley Congenital Hip Femur (85-3060)
- Applicant
- Codman & Shurtleff, Inc.
Mchenry, IL, US - Received
- November 8, 1976
- Decision date
- November 23, 1976
- 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 |
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| K171862 | GALAXY G3 Mini Microcoil Delivery SystemHCG · Traditional | 09/25/2017SE |
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Questions and answers
When was Charnley Congenital Hip Femur (85-3060) cleared by the FDA?
Charnley Congenital Hip Femur (85-3060) (K761002) received a 510(k) decision of Substantially Equivalent on November 23, 1976, 15 days after the submission was received.
What is the product code of K761002?
The FDA product code is JDG – Prosthesis, Hip, Femoral Component, Cemented, Metal, a Class II (moderate risk) device regulated under 21 CFR 888.3360.