Theken Large Cement Restrictor
FDA 510(k) K012462 · Theken Surgical,Llc
510(k) numberK012462
Submission
- Device name
- Theken Large Cement Restrictor
- Applicant
- Theken Surgical,Llc
Barberton, OH, US - Received
- August 1, 2001
- Decision date
- October 29, 2001
- Decision
- Unknown (SESU)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
|---|---|---|
| K050058 | Theken Reveal VBR SystemMQP · Traditional | 05/17/2005SE |
| K041592 | Coral Spinal SystemKWP · Traditional | 09/16/2004SE |
| K032064 | Theken Cpod/Lpod Vertebral Body Replacement SystemMQP · Traditional | 02/20/2004SE |
| K012278 | Theken Small Cement RestrictorJDK · Traditional | 10/17/2001SESU |
| K010466 | Tether AcfsKWQ · Traditional | 05/16/2001SE |
| K994382 | Nonlinear Taper Lag ScrewHWC · Traditional | 03/10/2000SE |
| K994383 | Dogbone AcfsKWQ · Traditional | 02/04/2000SE |
| K983622 | Bodyform Thoraco-Lumbar Fixation SystemKWQ · Traditional | 12/30/1998SE |
Questions and answers
When was Theken Large Cement Restrictor cleared by the FDA?
Theken Large Cement Restrictor (K012462) received a 510(k) decision of Unknown on October 29, 2001, 89 days after the submission was received.
What is the product code of K012462?
The FDA product code is JDK – Prosthesis, Hip, Cement Restrictor, a Class II (moderate risk) device regulated under 21 CFR 878.3300.