Omniflex-C Uhmwpe Mid-Shaft Restrictor
FDA 510(k) K923616 · Osteonics Corp.
510(k) numberK923616
Submission
- Device name
- Omniflex-C Uhmwpe Mid-Shaft Restrictor
- Applicant
- Osteonics Corp.
Allendale, NJ, US - Received
- July 21, 1992
- Decision date
- October 30, 1992
- Decision
- Substantially Equivalent (SESE)
- 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
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| K060247 | Life Spine Cement RestrictorJDK · Traditional | Life Spine | 05/11/2006SESU |
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| 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 |
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| 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 Omniflex-C Uhmwpe Mid-Shaft Restrictor cleared by the FDA?
Omniflex-C Uhmwpe Mid-Shaft Restrictor (K923616) received a 510(k) decision of Substantially Equivalent on October 30, 1992, 101 days after the submission was received.
What is the product code of K923616?
The FDA product code is JDK – Prosthesis, Hip, Cement Restrictor, a Class II (moderate risk) device regulated under 21 CFR 878.3300.