Panels › General, Plastic Surgery › Product code KKY · Class 2
Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
Regulation 878.3500
0510(k)s in 12 months (25 all time)
0recalls in 12 months (9 all time)
9recalls that name a 510(k)
Top companies in KKY
| Company | 510(k)s | Recalls |
|---|---|---|
| Ceremed , Inc. | 4 | 0 |
| Stryker Craniomaxillofacial Division | 0 | 4 |
| Matrix Surgical Holdings, LLC | 0 | 3 |
| Oxford Performance Materials | 2 | 0 |
| Associated Hospital Services, Inc. | 1 | 0 |
| Biomet, Inc. | 1 | 0 |
| Biomet Microfixation, LLC | 0 | 1 |
| Biomet Ussc Orthopedics | 1 | 0 |
| Hohenstein Enterprises, Inc. | 1 | 0 |
| Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 15, 2021 | K211514 | Longeviti PorousFit implant Longeviti Neuro Solutions, LLC | KKY |
| Jul 20, 2016 | K161052 | OsteoFab Patient Specific Facial Device Oxford Performance Materials, Inc. | KKY |
| Jul 14, 2016 | K160988 | Biopor, AOC Porous Polyethylene, Cerepor Ceremed , Inc. | KKY |
| Apr 16, 2015 | K141880 | BIOPOR AOC POROUS POLYETHYLENE, CEREPOR Ceremed , Inc. | KKY |
| Jul 28, 2014 | K133809 | OSTEOFAB PATIENT SPECIFIC FACIAL DEVICE Oxford Performance Materials | KKY |
| Jun 13, 2014 | K140437 | SU-POR SURGICAL IMPLANT Poriferous, LLC | KKY |
| May 14, 2014 | K133046 | OMNIPORE CUSTOMIZED SURGICAL IMPLANTS Matrix Surgical Holdings, LLC/Matrix Surgical USA | KKY |
| Jul 31, 2013 | K123908 | OMNIPORE SURGICAL IMPLANTS AND ACCESSORIES Matrix Surgical USA | KKY |
| Nov 16, 2011 | K111323 | SYNTHES SYNPOR HD POROUS POLYETHYLENE THRER DIMENSIONAL IMPLANTS Synthes, Inc. | KKY |
| Oct 26, 2010 | K103010 | STRYKER PATIENT SPECIFIC POLYMER IMPLANT Howmedica Osteonics Corp., Dba Stryker Orthopaedics | KKY |
| Apr 21, 2008 | K080507 | AOC POROUS POLYETHYLENE, AOC POROUS HDPE, AOC POROUS POLYETHYLENE SURGICAL IMPLANT Ceremed , Inc. | KKY |
| Oct 19, 2007 | K071937 | BONALIVE GRANULES AND BONALIVE PLATES Vivoxid , Ltd. | KKY |
| Apr 15, 2005 | K043250 | STRYKER PATIENT SPECIFIC POLYMER IMPLANT Stryker Leibinger | KKY |
| Mar 2, 2005 | K043133 | AOC POROUS POLYETHYLENE, AOC POROUS HDPE, AOC POROUS POLYETHYLENE SURGICAL IMPLANT, CEREPOR Ceremed , Inc. | KKY |
| Oct 16, 2002 | K021889 | SURGIFORM AUGMENTATION MATERIAL (S.F.A.M.) Surgical Technology Laboratories, Inc. | KKY |
| Oct 9, 2002 | K022665 | POROUS HDPE SURGICAL IMPLANTS, TO BE DISTRIBUTED UNDER VARIOUS TRADEMARKS INCLUDING EPOR, BIOPOR, MINOPOR & P-HDPE Hohenstein Enterprises, Inc. | KKY |
| May 16, 2002 | K013764 | IMMIX BONE GRAFT EXTENDER Osteogenics Biomedical, Inc. | KKY |
| Aug 18, 1995 | K951474 | TLC SURGICAL DRAPES Tlc Tech Lab Clothes, Inc. | KKY |
| Nov 4, 1994 | K934861 | HARD TISSUE REPLACEMENT (HTR) GRANULAR Poly-Medics,Inc. | KKY |
| Sep 30, 1994 | K935199 | SURGICAL APPAREL Associated Hospital Services, Inc. | KKY |
| Sep 2, 1993 | K924935 | HARD TISSUE REPLACE(HTR(R))-PATIENT-MATCH IMPLANT Polyclinic Medical Center | KKY |
| Feb 3, 1992 | K915445 | MAALEABLE FACIAL IMPLANT Biomet Ussc Orthopedics | KKY |
| Nov 23, 1990 | K904111 | HTR POLYMER, HTR-MX United States Surgical, A Division of Tyco Healthc | KKY |
| Mar 8, 1990 | K894478 | UHMWPE SURGICAL MESH Biomet, Inc. | KKY |
| Aug 14, 1978 | K781019 | SURG. GOWN & DRAPE, LOW LINT TREATMENT Kimberly-Clark Corp. | KKY |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.