Exeter Mesh
FDA 510(k) K963940 · Howmedica, Inc.
510(k) numberK963940
Submission
- Device name
- Exeter Mesh
- Applicant
- Howmedica, Inc.
Rutherford, NJ, US - Received
- October 1, 1996
- Decision date
- February 13, 1997
- 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 |
| 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 |
| K890450 | Intermedics Apr(Tm) II Femoral ComponentJDJ · Traditional | Intermedics Orthopedics | 08/09/1989SN |
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| 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 Exeter Mesh cleared by the FDA?
Exeter Mesh (K963940) received a 510(k) decision of Substantially Equivalent on February 13, 1997, 135 days after the submission was received.
What is the product code of K963940?
The FDA product code is JDJ – Mesh, Surgical, Acetabular, Hip, Prosthesis, a Class II (moderate risk) device regulated under 21 CFR 878.3300.