The Hedrocel Trabecular Metal Reconstruction System, Model 06-165-ZZZZ
FDA 510(k) K033384 · Implex Corp.
510(k) numberK033384
Submission
- Device name
- The Hedrocel Trabecular Metal Reconstruction System, Model 06-165-ZZZZ
- Applicant
- Implex Corp.
Allendale, NJ, US - Received
- October 23, 2003
- Decision date
- November 19, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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| K061465 | Kmi Cement Restrictor ImplantJDK · Traditional | Kinetikos Medical, Inc. | 10/05/2006SESU |
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| 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 |
|---|---|---|
| K051978 | Trabecular Metal Vertebral Body ReplacementMQP · Special | 09/23/2005SE |
| K051196 | Trabecular Metal Vertebral Body Replacement, Model 06-165-011X1 and 06-166-051X1MQP · Special | 06/17/2005SE |
| K040487 | Trabecular Metal Knee System AugmentsMBH · Traditional | 12/21/2004SE |
| K040630 | Trabecular Metal Femoral Cone Augments, Model 03-125-ZZZZJWH · Traditional | 09/30/2004SE |
| K040756 | The Trabecular Metal Reconstruction System, Model 10-340-XXXXXFTM · Special | 07/14/2004SE |
| K031962 | Nexgen Trabecular Metal Tibial Cone AugmentsJWH · Traditional | 01/08/2004SE |
| K032527 | Hedrocel Vertebral Body ReplacementMQP · Special | 10/31/2003SE |
| K032344 | The Hedrocel Trabecular Metal Reconstruction System Model 10-330EZX · Special | 10/02/2003SE |
| K031449 | Modification to the Trabecular Metal Glenoid - Bigliani/Flatow the Complete Shoulder…KWS · Traditional | 09/23/2003SE |
| K032282 | Modification to Hedrocel Trabecular Metal Reconstruction SystemEZX · Special | 08/21/2003SE |
Questions and answers
When was The Hedrocel Trabecular Metal Reconstruction System, Model 06-165-ZZZZ cleared by the FDA?
The Hedrocel Trabecular Metal Reconstruction System, Model 06-165-ZZZZ (K033384) received a 510(k) decision of Substantially Equivalent on November 19, 2003, 27 days after the submission was received.
What is the product code of K033384?
The FDA product code is JDK – Prosthesis, Hip, Cement Restrictor, a Class II (moderate risk) device regulated under 21 CFR 878.3300.