Cement Restrictor
FDA 510(k) K840413 · American Ortomed Corp.
510(k) numberK840413
Submission
- Device name
- Cement Restrictor
- Applicant
- American Ortomed Corp.
Mchenry, IL, US - Received
- January 31, 1984
- Decision date
- March 5, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JDK – Prosthesis, Hip, Cement Restrictor
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.3300
- Specialty
- General, Plastic Surgery
- Implant
- Yes
Other 510(k)s with product code JDK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K210062 | Mectaplug PE IIJDK · Traditional | Medacta International S.A. | 04/08/2021SE |
| K061465 | Kmi Cement Restrictor ImplantJDK · Traditional | Kinetikos Medical, Inc. | 10/05/2006SESU |
| K061698 | Modification to Life Spine Cement RestrictorJDK · Special | Life Spine | 07/12/2006SE |
| K060247 | Life Spine Cement RestrictorJDK · Traditional | Life Spine | 05/11/2006SESU |
| K060132 | Spinal USA Cement Restrictor SystemJDK · Traditional | Spinal USA | 03/16/2006SE |
| K051371 | Interbody Innovations Cement RestrictorJDK · Traditional | Interbody Innovations, Llp | 12/06/2005SESU |
| K051836 | Skelite Resorbable Cement RestrictorJDK · Traditional | Millenium Biologix, Inc. | 11/21/2005SESU |
| K051607 | Novaspine Cement Restrictor NSCRJDK · Traditional | Novaspine, LLC | 10/07/2005SE |
| K052367 | Scient'X Cement RestrictorJDK · Traditional | Scient'X | 10/05/2005SESU |
| K041382 | Polygraft BGS; Bone Graft SubstituteJDK · Traditional | Osteobiologics, Inc. | 06/17/2005SESU |
More from Osteobiologics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K842518 | Uniloc-Cementless & Self Tap AcetabularKWA · Traditional | 01/30/1985SE |
| K842466 | Titanium Mittelmeier Type AcetabularKWA · Traditional | 01/30/1985SE |
| K842465 | UnilocKWL · Traditional | 11/19/1984SE |
| K820719 | The Icr Knee · Traditional | 05/12/1982SE |
| K780497 | Spheristem Total Hip ProsthesisJDG · Traditional | 06/14/1978SE |
Questions and answers
When was Cement Restrictor cleared by the FDA?
Cement Restrictor (K840413) received a 510(k) decision of Substantially Equivalent on March 5, 1984, 34 days after the submission was received.
What is the product code of K840413?
The FDA product code is JDK – Prosthesis, Hip, Cement Restrictor, a Class II (moderate risk) device regulated under 21 CFR 878.3300.