Osteonics N2/VAC Packaging Process
FDA 510(k) K955421 · Osteonics Corp.
510(k) numberK955421
Submission
- Device name
- Osteonics N2/VAC Packaging Process
- Applicant
- Osteonics Corp.
Allendale, NJ, US - Received
- November 28, 1995
- Decision date
- February 21, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JWH – Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3560
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code JWH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260063 | GSPE SpacerJWH · Traditional | The General Hospital Corporation, d/b/a… | 09/11/2026SE |
| K262293 | EVOLUTION MPX Total Knee SystemJWH · Traditional | Suzhou Microport Orthorecon Co., Ltd. | 09/10/2026SE |
| K262341 | b-ONE® Mobio Total Knee System Revision Cemented Tibial Augments, Stem Extensions and…JWH · Traditional | B-One Ortho, Corp. | 09/08/2026SE |
| K262130 | ATTUNE Revision Knee SystemJWH · Traditional | Depuy Orthopaedics, Inc. | 09/04/2026SE |
| K253961 | SK Knee SystemJWH · Traditional | Just Medical Devices (Tianjin) Co., Ltd. | 09/01/2026SE |
| K261563 | Freedom Total Knee System (E-Poly Tibial Liners)JWH · Traditional | Maxx Orthopedics, Inc. | 08/07/2026SE |
| K262251 | ACTIFY Total Knee System, ACTIFY 3D Total Knee System (ACTIFY MC Tibial Insert)JWH · Special | Globus Medical, Inc. | 07/31/2026SE |
| K261734 | Klassic Infection Spacer SystemJWH · Traditional | Total Joint Orthopedics, Inc. | 07/23/2026SE |
| K261458 | ATTUNE Total Knee System; ATTUNE Cementless Knee SystemJWH · Traditional | DePuy Ireland UC | 06/25/2026SE |
| K261032 | NovoKnee (SteriKnee)JWH · Special | NovoSource | 04/27/2026SE |
More from NovoSource
| 510(k) | Device | Decision |
|---|---|---|
| K983657 | Osteonics Series 7000 Ad Tibial TrayHRY · Traditional | 04/06/2000SE |
| K980070 | Osteonics Ha-Coated DevicesMEH · Traditional | 07/23/1999SE |
| K984375 | Osteonics Spinal System - Sacral Offset Connector AssemblyKWP · Traditional | 04/30/1999SE |
| K982798 | Osteonics Anterior Cervical Compression Plating SystemKWQ · Traditional | 03/25/1999SE |
| K984585 | Osteonics +10 Unipolar Adaptor SleeveKWL · Traditional | 02/24/1999SE |
| K990203 | Osteonics Primary Secur-Fit Plus Hip StemsMEH · Special | 02/18/1999SE |
| K990158 | Osteonics Combination Screw Ring/BlockerMNI · Special | 02/01/1999SE |
| K984302 | Osteonics Spinal System Cylindrical Bone ScrewsMNH · Special | 12/18/1998SE |
| K984353 | Osteo 9MM Ic Tibial NailHSB · Special | 12/16/1998SE |
| K983502 | Osteonics Secur-Fit Ad Generation II Acetabular Component SystemLPH · Traditional | 12/16/1998SE |
Questions and answers
When was Osteonics N2/VAC Packaging Process cleared by the FDA?
Osteonics N2/VAC Packaging Process (K955421) received a 510(k) decision of Substantially Equivalent on February 21, 1996, 85 days after the submission was received.
What is the product code of K955421?
The FDA product code is JWH – Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer, a Class II (moderate risk) device regulated under 21 CFR 888.3560.