Brigham II Total Hip System
FDA 510(k) K812687 · Hexcel Medical
510(k) numberK812687
Submission
- Device name
- Brigham II Total Hip System
- Applicant
- Hexcel Medical
Mchenry, IL, US - Received
- September 22, 1981
- Decision date
- October 2, 1981
- 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
Other 510(k)s with product code JDG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K840416 | HexceliteITG · Traditional | 03/23/1984SE |
| K820890 | Urethane Orthopaedic Casting TapeITG · Traditional | 06/23/1982SE |
| K812669 | Seattle II Total Hip SystemJDG · Traditional | 10/02/1981SE |
| K812068 | Proposed Controls for Dosimetric ReleaseLIB · Traditional | 09/08/1981SE |
| K811164 | Urethane Orthopaedic Casting TapeITG · Traditional | 05/27/1981SE |
| K810957 | Marcove Intramedullary RodHSB · Traditional | 04/17/1981SE |
| K810956 | Marcove Humeral RodHSB · Traditional | 04/17/1981SE |
| K810230 | Condylar Knee W/Metal Encapsulated TibHRY · Traditional | 03/06/1981SE |
| K800051 | Hexcel Femoral Component Hip ProsthesisJDG · Traditional | 01/28/1980SE |
| K800050 | Anitomic Total Hip SystemJDG · Traditional | 01/24/1980SE |
Questions and answers
When was Brigham II Total Hip System cleared by the FDA?
Brigham II Total Hip System (K812687) received a 510(k) decision of Substantially Equivalent on October 2, 1981, 10 days after the submission was received.
What is the product code of K812687?
The FDA product code is JDG – Prosthesis, Hip, Femoral Component, Cemented, Metal, a Class II (moderate risk) device regulated under 21 CFR 888.3360.