Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
FDA product code KKY · 21 cleared devices
Class 2
General, Plastic Surgery
- Regulation
- 21 CFR 878.3500
- Review panel
- SU
- Implant
- Yes
- Life sustaining
- No
- Third party review
- No
- GMP exempt
- No
- Clearance span
- 1978-08-14 – 2021-07-15
KKY
2021-07-15
KKY
2016-07-20
OsteoFab Patient Specific Facial Device
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KKY
2016-07-14
Biopor, AOC Porous Polyethylene, Cerepor
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KKY
2013-07-31
OMNIPORE SURGICAL IMPLANTS AND ACCESSORIES
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KKY
2011-11-16
SYNTHES SYNPOR HD POROUS POLYETHYLENE THRER DIMENSIONAL IMPLANTS
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KKY
2010-10-26
STRYKER PATIENT SPECIFIC POLYMER IMPLANT
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KKY
2008-04-21
AOC POROUS POLYETHYLENE, AOC POROUS HDPE, AOC POROUS POLYETHYLENE SURGICAL IMPLANT
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KKY
2007-10-19
BONALIVE GRANULES AND BONALIVE PLATES
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KKY
2005-04-15
STRYKER PATIENT SPECIFIC POLYMER IMPLANT
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KKY
2005-03-02
AOC POROUS POLYETHYLENE, AOC POROUS HDPE, AOC POROUS POLYETHYLENE SURGICAL IMPLANT, CEREPOR
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KKY
2002-10-16
SURGIFORM AUGMENTATION MATERIAL (S.F.A.M.)
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KKY
2002-10-09
POROUS HDPE SURGICAL IMPLANTS, TO BE DISTRIBUTED UNDER VARIOUS TRADEMARKS INCLUDING EPOR, BIOPOR, MINOPOR & P-HDPE
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KKY
2002-05-16
IMMIX BONE GRAFT EXTENDER
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KKY
1995-08-18
TLC SURGICAL DRAPES
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KKY
1994-11-04
HARD TISSUE REPLACEMENT (HTR) GRANULAR
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KKY
1994-09-30
SURGICAL APPAREL
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KKY
1993-09-02
HARD TISSUE REPLACE(HTR(R))-PATIENT-MATCH IMPLANT
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KKY
1992-02-03
MAALEABLE FACIAL IMPLANT
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KKY
1990-11-23
HTR POLYMER, HTR-MX
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KKY
1990-03-08
UHMWPE SURGICAL MESH
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KKY
1978-08-14
SURG. GOWN & DRAPE, LOW LINT TREATMENT
View details →No matching devices.
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