Oti Bone Cement Plug
FDA 510(k) K030608 · Osteoimplant Technology, Inc.
510(k) numberK030608
Submission
- Device name
- Oti Bone Cement Plug
- Applicant
- Osteoimplant Technology, Inc.
Hunt Valley, MD, US - Received
- February 26, 2003
- Decision date
- June 12, 2003
- Decision
- Unknown (SESU)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|
| K040685 | Z - Series Modular Total Hip System Plasma CoatedLWJ · Traditional | 01/25/2005SE |
| K041443 | Oti Alumina Ceramic Femoral Head SystemLZO · Special | 11/16/2004SE |
| K040225 | Oti Alumina Ceramic Femoral Head SystemKWZ · Traditional | 05/06/2004SE |
| K032729 | Z-Series Modular Total Hip SystemLPH · Traditional | 12/03/2003SE |
| K022779 | Oti Unicondular Interpositional SpacerHSH · Traditional | 11/20/2002SE |
| K021822 | R120 Modular Total Hip SystemJDI · Traditional | 07/23/2002SE |
| K012762 | MJS Posterior Stabilized Knee SystemHRY · Traditional | 12/11/2001SE |
| K011774 | R120 Modular Total Hip SystemJDI · Traditional | 09/05/2001SE |
| K003316 | Oti Ceramic Femoral Head SystemLZO · Traditional | 01/19/2001SE |
| K003199 | Triad II Modular Total Hip SystemLPH · Traditional | 01/10/2001SE |
Questions and answers
When was Oti Bone Cement Plug cleared by the FDA?
Oti Bone Cement Plug (K030608) received a 510(k) decision of Unknown on June 12, 2003, 106 days after the submission was received.
What is the product code of K030608?
The FDA product code is JDK – Prosthesis, Hip, Cement Restrictor, a Class II (moderate risk) device regulated under 21 CFR 878.3300.