Intermedics Apr(Tm) II Femoral Component
FDA 510(k) K890450 · Intermedics Orthopedics
510(k) numberK890450
Submission
- Device name
- Intermedics Apr(Tm) II Femoral Component
- Applicant
- Intermedics Orthopedics
Austin, TX, US - Received
- January 30, 1989
- Decision date
- August 9, 1989
- Decision
- Substantially Equivalent for Some Indications (SN)
- Type
- Traditional 510(k)
Device classification
- Product code
- JDJ – Mesh, Surgical, Acetabular, Hip, Prosthesis
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.3300
- Specialty
- General, Plastic Surgery
- Implant
- Yes
Other 510(k)s with product code JDJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K972760 | Link, Acetabular Revision Mesh CupJDJ · Traditional | Link America, Inc. | 10/22/1997SE |
| K970957 | Osteonics Restoration Acetabular RingJDJ · Traditional | Osteonics Corp. | 06/03/1997SE |
| K963940 | Exeter MeshJDJ · Traditional | Howmedica, Inc. | 02/13/1997SE |
| K962541 | Reflection Acetabular Reinforcement RingsJDJ · Traditional | Smith & Nephew Richards, Inc. | 09/17/1996SE |
| K962007 | Protrusion CagesJDJ · Traditional | Depuy, Inc. | 08/01/1996SE |
| K925883 | Osteonics Microstructured Acetabular ComponentsJDJ · Traditional | Osteonics Corp. | 06/15/1993SE |
More from Osteonics Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K970300 | Natural-Hip System Porous Stem with Ha/CstiLPH · Traditional | 07/03/1997SE |
| K970498 | Natural-Knee II Revision Femoral Spacer LugsJWH · Traditional | 04/30/1997SE |
| K970166 | Natural-Hip System Cocr Revision StemLZO · Traditional | 04/08/1997SE |
| K970567 | Select Shoulder Curved-Back Pegged All Poly GlenoidsKWT · Traditional | 02/27/1997SE |
| K964357 | Natural-Hip System Cocr StemLZO · Traditional | 01/27/1997SE |
| K964350 | Modula Options for Severe Bone Loss and TraumaJDI · Traditional | 01/16/1997SE |
| K962190 | Patellofemoral Joint ProsthesisKRR · Traditional | 10/28/1996SE |
| K963266 | Natural Hip System Porous Stem - Collarless, CollaredLPH · Traditional | 10/15/1996SE |
| K963155 | Intermoore Fracture Hip Stem (Modify)LWJ · Traditional | 10/01/1996SE |
| K962315 | Select Shoulder Cocr Humeral Stem ComponentKWT · Traditional | 09/03/1996SE |
Questions and answers
When was Intermedics Apr(Tm) II Femoral Component cleared by the FDA?
Intermedics Apr(Tm) II Femoral Component (K890450) received a 510(k) decision of Substantially Equivalent for Some Indications on August 9, 1989, 191 days after the submission was received.
What is the product code of K890450?
The FDA product code is JDJ – Mesh, Surgical, Acetabular, Hip, Prosthesis, a Class II (moderate risk) device regulated under 21 CFR 878.3300.