Stryker Patient Specific Polymer Implant
FDA 510(k) K043250 · Stryker Leibinger
510(k) numberK043250
Submission
- Device name
- Stryker Patient Specific Polymer Implant
- Applicant
- Stryker Leibinger
Kalamazoo, MI, US - Received
- November 23, 2004
- Decision date
- April 15, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KKY – Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.3500
- Specialty
- General, Plastic Surgery
- Implant
- Yes
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| K161052 | OsteoFab Patient Specific Facial DeviceKKY · Special | Oxford Performance Materials, Inc. | 07/20/2016SE |
| K160988 | Biopor, AOC Porous Polyethylene, CereporKKY · Traditional | Ceremed , Inc. | 07/14/2016SE |
| K141880 | Biopor Aoc Porous Polyethylene, CereporKKY · Traditional | Ceremed , Inc. | 04/16/2015SE |
| K133809 | Osteofab Patient Specific Facial DeviceKKY · Traditional | Oxford Performance Materials | 07/28/2014SE |
| K140437 | Su-Por Surgical ImplantKKY · Traditional | Poriferous, LLC | 06/13/2014SE |
| K133046 | Omnipore Customized Surgical ImplantsKKY · Traditional | Matrix Surgical Holdings, LLC/Matrix Surgical USA | 05/14/2014SE |
| K123908 | Omnipore Surgical Implants and AccessoriesKKY · Traditional | Matrix Surgical USA | 07/31/2013SE |
| K111323 | Synthes Synpor HD Porous Polyethylene Threr Dimensional ImplantsKKY · Traditional | Synthes, Inc. | 11/16/2011SE |
| K103010 | Stryker Patient Specific Polymer ImplantKKY · Special | Howmedica Osteonics Corp., Dba Stryker… | 10/26/2010SE |
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Questions and answers
When was Stryker Patient Specific Polymer Implant cleared by the FDA?
Stryker Patient Specific Polymer Implant (K043250) received a 510(k) decision of Substantially Equivalent on April 15, 2005, 143 days after the submission was received.
What is the product code of K043250?
The FDA product code is KKY – Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction, a Class II (moderate risk) device regulated under 21 CFR 878.3500.