510(k) K924935
- Device
- HARD TISSUE REPLACE(HTR(R))-PATIENT-MATCH IMPLANT
- Applicant
- POLYCLINIC MEDICAL CENTER
- 510(k) number
- K924935
- Product code
- KKY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1993-09-02
- Date received
- 1992-09-30
- Regulation
- 878.3500
- Classification name
- Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
- Medical specialty
- General & Plastic Surgery
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- MARY L VERSTYNEN
- Address
- P.O. Box 587 Warsaw IN US 46581 46581
FDA Registration Numbers#
- 3008812560
- 3010781616
- 3009383407
- 3013944123
- 1032347
- 2249697
- 2024024
- 3009582362
- 1825527
- 2028924
- 3014680740
Source Documents#
Other 510(k) Records For Product Code KKY #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K211514 | Longeviti PorousFit implant | Longeviti Neuro Solutions, LLC | 2021-07-15 |
| K161052 | OsteoFab Patient Specific Facial Device | Oxford Performance Materials, Inc. | 2016-07-20 |
| K160988 | Biopor, AOC Porous Polyethylene, Cerepor | Ceremed , Inc. | 2016-07-14 |
| K141880 | BIOPOR AOC POROUS POLYETHYLENE, CEREPOR | Ceremed , Inc. | 2015-04-16 |
| K133809 | OSTEOFAB PATIENT SPECIFIC FACIAL DEVICE | Oxford Performance Materials | 2014-07-28 |
| K140437 | SU-POR SURGICAL IMPLANT | Poriferous, LLC | 2014-06-13 |
| K133046 | OMNIPORE CUSTOMIZED SURGICAL IMPLANTS | Matrix Surgical Holdings, LLC/Matrix Surgical USA | 2014-05-14 |
| K123908 | OMNIPORE SURGICAL IMPLANTS AND ACCESSORIES | Matrix Surgical USA | 2013-07-31 |
| K111323 | SYNTHES SYNPOR HD POROUS POLYETHYLENE THRER DIMENSIONAL IMPLANTS | Synthes, Inc. | 2011-11-16 |
| K103010 | STRYKER PATIENT SPECIFIC POLYMER IMPLANT | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2010-10-26 |
| K080507 | AOC POROUS POLYETHYLENE, AOC POROUS HDPE, AOC POROUS POLYETHYLENE SURGICAL IMPLANT | Ceremed , Inc. | 2008-04-21 |
| K071937 | BONALIVE GRANULES AND BONALIVE PLATES | Vivoxid , Ltd. | 2007-10-19 |
| K043250 | STRYKER PATIENT SPECIFIC POLYMER IMPLANT | Stryker Leibinger | 2005-04-15 |
| K043133 | AOC POROUS POLYETHYLENE, AOC POROUS HDPE, AOC POROUS POLYETHYLENE SURGICAL IMPLANT, CEREPOR | Ceremed , Inc. | 2005-03-02 |
| K021889 | SURGIFORM AUGMENTATION MATERIAL (S.F.A.M.) | Surgical Technology Laboratories, Inc. | 2002-10-16 |
Legacy Summary#
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FDA Review#
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