Product Code: KKY


Products Classified as KKY

5717Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial ReconstructionPolytetrafluoroethylene With Carbon Fibers Composite Implant Material.

Total Product Life Cycle (TPLC) Devices

5717Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial ReconstructionPolytetrafluoroethylene With Carbon Fibers Composite Implant Material.

FDA Consensus Standards

Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction [32309]21 CFR §878.3500 🔎

Pre-market Notifications for KKY

K211514Longeviti PorousFit ImplantLongeviti Neuro Solutions, LLC
K161052OsteoFab Patient Specific Facial DeviceOXFORD PERFORMANCE MATERIALS, INC.
K160988Biopor, AOC Porous Polyethylene, CereporCEREMED, INC.
K141880BIOPOR AOC POROUS POLYETHYLENE, CEREPORCEREMED, INC.
K140437SU-POR SURGICAL IMPLANTPORIFEROUS, LLC.
K133809OSTEOFAB PATIENT SPECIFIC FACIAL DEVICEOXFORD PERFORMANCE MATERIALS
K133046OMNIPORE CUSTOMIZED SURGICAL IMPLANTSMATRIX SURGICAL HOLDINGS, LLC/MATRIX SURGICAL USA
K123908OMNIPORE SURGICAL IMPLANTS AND ACCESSORIESMATRIX SURGICAL USA
K111323SYNTHES SYNPOR HD POROUS POLYETHYLENE THRER DIMENSIONAL IMPLANTSSYNTHES INC
K103010STRYKER PATIENT SPECIFIC POLYMER IMPLANTHOWMEDICA OSTEONICS CORP DBA STRYKER ORTHOPAEDICS
K080507AOC POROUS POLYETHYLENE, AOC POROUS HDPE, AOC POROUS POLYETHYLENE SURGICAL IMPLANTCEREMED, INC.
K071937BONALIVE GRANULES AND BONALIVE PLATESVIVOXID LTD.
K043250STRYKER PATIENT SPECIFIC POLYMER IMPLANTSTRYKER LEIBINGER
K043133AOC POROUS POLYETHYLENE, AOC POROUS HDPE, AOC POROUS POLYETHYLENE SURGICAL IMPLANT, CEREPORCEREMED, INC.
K022665POROUS HDPE SURGICAL IMPLANTS, TO BE DISTRIBUTED UNDER VARIOUS TRADEMARKS INCLUDING EPOR, BIOPOR, MINOPOR & P-HDPEHOHENSTEIN ENTERPRISES, INC.

Global Unique Device Identification Database

00810042037663Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
00810042037502Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
00810042037458Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
00810042037427Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
00810042037373Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
00810042036239Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
00810042036048Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
00810042035942Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
00810042035935Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
00810042035119Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
00810042034532Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
00810042034082Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
00810042034044Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
00810042034037Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
00810042033740Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction

Maude Adverse Events

SU-POR SURGICAL IMPLANTSPORIFEROUS, LLC2020-03-13
HTR-PMI A.B. 1953-20190619 RIGHT TOP PARIETAL IMPLANTBIOMET MICROFIXATION2020-02-13
SU-POR SURGICAL IMPLANTSPORIFEROUS, LLC2020-01-15
HTR PMI MA 1967-20191022 RIGHT FRONTAL TEMPORAL PARIETAL IMPLANTBIOMET MICROFIXATION2020-01-09
CMF CUSTOMIZED IMPLANT KIT LARGESTRYKER ORTHOPAEDICS-MAHWAH2020-01-07
HTR-PMI G.S.1958 RIGHT FRONTAL PARIETAL SPHENOID TEMPORALBIOMET MICROFIXATION2019-08-09
HTR PMI A.F.M. RIGHT FRONTAL TEMPORAL PARIETAL IMPLANTBIOMET MICROFIXATION2019-06-19
8374/19 LEFT FRONTAL PARIETAL TEMPORAL IMPLANTBIOMET MICROFIXATION2019-04-25
HTR PMI R.T.1959 FRONTAL IMPLANTBIOMET MICROFIXATION2019-04-16
HTR-PEKKOXFORD PERFORMANCE MATERIALS2019-04-03
HTR-PEKKOXFORD PERFORMANCE MATERIALS2019-03-26
HTR-PEKKOXFORD PERFORMANCE MATERIALS2019-03-26
HTR-PMI VASQUE TORRES LEFT FRONTAL SPHENOID PARIETAL TEMPORAL IMPLANTBIOMET MICROFIXATION2019-03-08
HTR-PMI VASQUE TORRES LEFT FRONTAL SPHENOID PARIETAL TEMPORAL IMPLANTBIOMET MICROFIXATION2019-03-08
HTR-PMI PACIENTE 2 BI-FRONTAL RIGHT IMPLANTBIOMET MICROFIXATION2019-03-06
HTR-PMI PACIENTE 1 BI-FRONTAL ORBITAL IMPLANTBIOMET MICROFIXATION2019-03-06
OMNIPORE? SURGICAL IMPLANTMATRIX SURGICAL USA2019-02-22
OMNIPORE SURGICAL IMPLANTMATRIX SURGICAL USA2019-02-22
OMNIPORE? SURGICAL IMPLANTMATRIX SURGICAL USA2019-02-22
HTR *PMI CORSI LEFT FRONTAL PARIETAL TEMPORAL IMPLANTBIOMET MICROFIXATION2019-02-08
OMNIPORE SURGICAL IMPLANT - TWO-PIECE CHIN - MEDIUMMATRIX SURGICAL USA2019-02-07
OMNIPORE SURGICAL IMPLANT - TWO-PIECE CHIN - LARGEMATRIX SURGICAL USA2019-02-07
OMNIOPORE SURGICAL IMPLANTMATRIX SURGICAL USA2019-02-06
HTR * PMI PURIFOY RIGHT FRONTAL SPHENOID PARIETAL TEMPORAL IMPLANTBIOMET MICROFIXATION2018-12-01
HTR-PMI ALONSO FERNAND RIGHT FRONTAL PARIETAL ORBITALBIOMET MICROFIXATION2018-11-16
HTR-PMI JORDAAN RIGHT MAXILLA ZYGOMA ORBITAL IMPLANTBIOMET MICROFIXATION2018-09-10
HTR-PMI JORDAAN RIGHT MAXILLA ZYGOMA ORBITAL IMPLANTBIOMET MICROFIXATION2018-09-10
HTR * PMI HARSCH LEFT FRONTAL SPHENOID PARIETAL TEMPORAL IMPLANTBIOMET MICROFIXATION2018-09-06
HTR * PMI GOBIEN LEFT FRONTAL SPHENOID PARIETAL TEMPORAL IMPLANTBIOMET MICROFIXATION2018-09-06
HTR * PMI GOBIEN RIGHT FRONTAL SPHENOID PARIETAL TEMPORAL IMPLANTBIOMET MICROFIXATION2018-09-06
HTR*PMI INACIO DOS SANTOS SILVA LEFT FRONTAL SPHENOID PARIETAL TEMPORAL IMPLANTBIOMET MICROFIXATION2018-08-30
HTR * PMI HIRSCH LEFT FRONTAL SPHENOID PARIETAL TEMPORAL IMPLANTBIOMET MICROFIXATION2018-08-06
HTR-PEKKOXFORD PERFORMANCE MATERIALS2018-07-19
HTR-PEKKOXFORD PERFORMANCE MATERIALS2018-07-19
HTR * PMI WALLRAVEN LEFT FRONTAL SPHENOID PARIETAL TEMPORAL IMPLANTBIOMET MICROFIXATION2018-04-03
HTR-PMI HASEWINKEL LEFT FRONTAL SPHENOID TEMPORAL IMPLANTBIOMET MICROFIXATION2018-03-12
HTR*PMI WALSH RIGHT FRONTAL PARIETAL TEMPORAL IMPLANTBIOMET MICROFIXATION2018-01-22
HTR-PMI HIRSCH LEFT FRONTAL SPENOID PARIETAL TEMPORAL IMPLANTBIOMET MICROFIXATION2018-01-10
HTR * PMI ACEBO SAENZ BI-FRONTAL PARIETAL IMPLANTBIOMET MICROFIXATION2018-01-03
HTR * PMI ACEBO SAENZ BI-FRONTAL PARIETAL IMPLANTBIOMET MICROFIXATION2018-01-03
HTR-PMI KOVALIOVAS LEFT FRONTAL SPHENOID PARIETAL TEMPORAL IMPLANTBIOMET MICROFIXATION2017-12-12
HTR-PMI KOVALIOVAS RIGHT FRONTAL SPHENOID PARIETAL TEMPORAL IMPLANTBIOMET MICROFIXATION2017-12-12
HTR-PMI KOVALIOVAS RIGHT FRONTAL SPHENOID PARIETAL TEMPORAL IMPLANTBIOMET MICROFIXATION2017-12-12
HTR-PMI KOVALIOVAS LEFT FRONTAL SPHENOID PARIETAL TEMPORAL IMPLANTBIOMET MICROFIXATION2017-12-12
HTR-PMI RIGHT FRONTAL SPHENOID PARIETAL TEMPORAL IMPLANTBIOMET MICROFIXATION2017-11-13
HTR-PMI RIGHT FRONTAL SPHENOID PARIETAL TEMPORAL IMPLANTBIOMET MICROFIXATION2017-11-13
HARD TISSUE REPLACE(HTR(R))-PATIENT-MATCH IMPLANTBIOMET MICROFIXATION2017-10-26
OMNIPORE SURGICAL IMPLANT - CRANIOTOMY GAP WEDGEMATRIX SURGICAL USA2017-10-25
HARD TISSUE REPLACE(HTR(R))-PATIENT-MATCH IMPLANTBIOMET MICROFIXATION2017-08-04
HARD TISSUE REPLACEMENT-PATIENT MATCHED LEFT FRONTAL SPHENOID PARIETAL TEMPORALBIOMET MICROFIXATION2017-07-12
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