KKY — Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction Class II
FDA product code KKY covers "Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction", a Class II medical device regulated under 21 CFR 878.3500. Submissions are reviewed by the General, Plastic Surgery panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KKY
- Device Class
- Class II
- Regulation Number
- 878.3500
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K211514 | longeviti neuro solutions | Longeviti PorousFit implant | July 15, 2021 |
| K161052 | oxford performance materials | OsteoFab Patient Specific Facial Device | July 20, 2016 |
| K160988 | ceremed | Biopor, AOC Porous Polyethylene, Cerepor | July 14, 2016 |
| K141880 | ceremed | BIOPOR AOC POROUS POLYETHYLENE, CEREPOR | April 16, 2015 |
| K133809 | oxford performance materials | OSTEOFAB PATIENT SPECIFIC FACIAL DEVICE | July 28, 2014 |
| K140437 | poriferous | SU-POR SURGICAL IMPLANT | June 13, 2014 |
| K133046 | matrix surgical holdings, llc/matrix surgical usa | OMNIPORE CUSTOMIZED SURGICAL IMPLANTS | May 14, 2014 |
| K123908 | matrix surgical usa | OMNIPORE SURGICAL IMPLANTS AND ACCESSORIES | July 31, 2013 |
| K111323 | synthes | SYNTHES SYNPOR HD POROUS POLYETHYLENE THRER DIMENSIONAL IMPLANTS | November 16, 2011 |
| K103010 | howmedica osteonics corp., dba stryker orthopaedics | STRYKER PATIENT SPECIFIC POLYMER IMPLANT | October 26, 2010 |
| K080507 | ceremed | AOC POROUS POLYETHYLENE, AOC POROUS HDPE, AOC POROUS POLYETHYLENE SURGICAL IMPLA | April 21, 2008 |
| K071937 | vivoxid | BONALIVE GRANULES AND BONALIVE PLATES | October 19, 2007 |
| K043250 | stryker leibinger | STRYKER PATIENT SPECIFIC POLYMER IMPLANT | April 15, 2005 |
| K043133 | ceremed | AOC POROUS POLYETHYLENE, AOC POROUS HDPE, AOC POROUS POLYETHYLENE SURGICAL IMPLA | March 2, 2005 |
| K021889 | surgical technology laboratories | SURGIFORM AUGMENTATION MATERIAL (S.F.A.M.) | October 16, 2002 |
| K022665 | hohenstein enterprises | POROUS HDPE SURGICAL IMPLANTS, TO BE DISTRIBUTED UNDER VARIOUS TRADEMARKS INCLUD | October 9, 2002 |
| K013764 | osteogenics biomedical | IMMIX BONE GRAFT EXTENDER | May 16, 2002 |
| K951474 | tlc tech lab clothes | TLC SURGICAL DRAPES | August 18, 1995 |
| K934861 | poly-medics | HARD TISSUE REPLACEMENT (HTR) GRANULAR | November 4, 1994 |
| K935199 | associated hospital services | SURGICAL APPAREL | September 30, 1994 |