FDA Product Code
FDA Product Code KKY — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.3500
510(k) Clearances — 25 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K211514 | Longeviti PorousFit implant | Longeviti Neuro Solutions, LLC | 2021-07-15 | Traditional | PDF ↗ |
| K161052 | OsteoFab Patient Specific Facial Device | Oxford Performance Materials, Inc. | 2016-07-20 | Special | PDF ↗ |
| K160988 | Biopor, AOC Porous Polyethylene, Cerepor | Ceremed , Inc. | 2016-07-14 | Traditional | PDF ↗ |
| K141880 | BIOPOR AOC POROUS POLYETHYLENE, CEREPOR | Ceremed , Inc. | 2015-04-16 | Traditional | PDF ↗ |
| K133809 | OSTEOFAB PATIENT SPECIFIC FACIAL DEVICE | Oxford Performance Materials | 2014-07-28 | Traditional | PDF ↗ |
| K140437 | SU-POR SURGICAL IMPLANT | Poriferous, LLC | 2014-06-13 | Traditional | PDF ↗ |
| K133046 | OMNIPORE CUSTOMIZED SURGICAL IMPLANTS | Matrix Surgical Holdings, LLC/Matrix Surgical USA | 2014-05-14 | Traditional | PDF ↗ |
| K123908 | OMNIPORE SURGICAL IMPLANTS AND ACCESSORIES | Matrix Surgical USA | 2013-07-31 | Traditional | PDF ↗ |
| K111323 | SYNTHES SYNPOR HD POROUS POLYETHYLENE THRER DIMENSIONAL IMPLANTS | Synthes, Inc. | 2011-11-16 | Traditional | PDF ↗ |
| K103010 | STRYKER PATIENT SPECIFIC POLYMER IMPLANT | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2010-10-26 | Special | PDF ↗ |
| K080507 | AOC POROUS POLYETHYLENE, AOC POROUS HDPE, AOC POROUS POLYETHYLENE SURGICAL IMPLANT | Ceremed , Inc. | 2008-04-21 | Traditional | PDF ↗ |
| K071937 | BONALIVE GRANULES AND BONALIVE PLATES | Vivoxid , Ltd. | 2007-10-19 | Traditional | PDF ↗ |
| K043250 | STRYKER PATIENT SPECIFIC POLYMER IMPLANT | Stryker Leibinger | 2005-04-15 | Traditional | PDF ↗ |
| K043133 | AOC POROUS POLYETHYLENE, AOC POROUS HDPE, AOC POROUS POLYETHYLENE SURGICAL IMPLANT, CEREPOR | Ceremed , Inc. | 2005-03-02 | Traditional | PDF ↗ |
| K021889 | SURGIFORM AUGMENTATION MATERIAL (S.F.A.M.) | Surgical Technology Laboratories, Inc. | 2002-10-16 | Traditional | PDF ↗ |
| K022665 | POROUS HDPE SURGICAL IMPLANTS, TO BE DISTRIBUTED UNDER VARIOUS TRADEMARKS INCLUDING EPOR, BIOPOR, MINOPOR & P-HDPE | Hohenstein Enterprises, Inc. | 2002-10-09 | Traditional | PDF ↗ |
| K013764 | IMMIX BONE GRAFT EXTENDER | Osteogenics Biomedical, Inc. | 2002-05-16 | Traditional | PDF ↗ |
| K951474 | TLC SURGICAL DRAPES | Tlc Tech Lab Clothes, Inc. | 1995-08-18 | Traditional | PDF ↗ |
| K934861 | HARD TISSUE REPLACEMENT (HTR) GRANULAR | Poly-Medics,Inc. | 1994-11-04 | Traditional | PDF ↗ |
| K935199 | SURGICAL APPAREL | Associated Hospital Services, Inc. | 1994-09-30 | Traditional | PDF ↗ |
| K924935 | HARD TISSUE REPLACE(HTR(R))-PATIENT-MATCH IMPLANT | Polyclinic Medical Center | 1993-09-02 | Traditional | PDF ↗ |
| K915445 | MAALEABLE FACIAL IMPLANT | Biomet Ussc Orthopedics | 1992-02-03 | Traditional | PDF ↗ |
| K904111 | HTR POLYMER, HTR-MX | United States Surgical, A Division of Tyco Healthc | 1990-11-23 | Traditional | PDF ↗ |
| K894478 | UHMWPE SURGICAL MESH | Biomet, Inc. | 1990-03-08 | Traditional | PDF ↗ |
| K781019 | SURG. GOWN & DRAPE, LOW LINT TREATMENT | Kimberly-Clark Corp. | 1978-08-14 | Traditional | PDF ↗ |
Product code KKY · Class II · General, Plastic Surgery. Data: openFDA.