Protrusion Cages
FDA 510(k) K962007 · Depuy, Inc.
510(k) numberK962007
Submission
- Device name
- Protrusion Cages
- Applicant
- Depuy, Inc.
Dayton, OH, US - Received
- May 22, 1996
- Decision date
- August 1, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
| K925883 | Osteonics Microstructured Acetabular ComponentsJDJ · Traditional | Osteonics Corp. | 06/15/1993SE |
| K890450 | Intermedics Apr(Tm) II Femoral ComponentJDJ · Traditional | Intermedics Orthopedics | 08/09/1989SN |
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Questions and answers
When was Protrusion Cages cleared by the FDA?
Protrusion Cages (K962007) received a 510(k) decision of Substantially Equivalent on August 1, 1996, 71 days after the submission was received.
What is the product code of K962007?
The FDA product code is JDJ – Mesh, Surgical, Acetabular, Hip, Prosthesis, a Class II (moderate risk) device regulated under 21 CFR 878.3300.