FDA.reportPublic FDA data

MEDPOR

Primary DI
07613252086307
Brand
MEDPOR
Company
Stryker Leibinger GmbH & Co. KG
Model
9566
Catalog number
9566
Device description
RZ Mandible Sizer Set (Sil Non-Ster)
Published
2016-08-31
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
FWPPROSTHESIS, CHIN, INTERNAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FWPProsthesis, Chin, InternalGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K922489000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K922489000MEDPOR SURG IMPLANT MATERIAL:PREFOR CRAN/FAC IMPLAPorex Technologies Corp.1992-09-02FWP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613252086307PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613252086307076132520863077613252086307

GMDN Terms#

Term, Definition table
TermDefinition
Surgical implant template, reusableA device designed to determine the appropriate size and placement of a non-dental implant for a patient prior to or during implantation surgery. It is typically available as a graduated set or an individual plate (e.g., a translucent plastic sheet or a cut metal shape) with patterns/sizes corresponding to the size of the implant to be used to aid the surgeon in final selection of implant size, placement, and/or adaption. It is used for, e.g., total- or partial-joint prostheses, bone fracture fixation implants (plates, nails, including skull plate implants) or other types of surgical implants. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
316153956
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
37613327122962NA29-9300329-930032018-04-13
04546540274250NA64-0013264-001322017-01-11
07613327122893NA29-9300129-930012017-12-01
07613327122909NA29-9200129-920012017-03-31
07613327122916NA29-9200329-920032017-03-31
07613327122930NA29-9200229-920022017-03-31
07613327122947NA29-9100229-910022017-03-31
07613327122978NA29-9300229-930022017-12-01
07613327123326NA29-9200429-920042017-03-31
37613154881872PINABALL6003-003-0906003-003-0902016-09-21
57613252088436TLS, Quintube663066302016-08-24
07613327465532NA92-0023292-002322019-05-03
07613327465549NA92-0023092-002302019-05-03
04546540134790NA01-0323001-032302017-01-11
04546540134974NA01-0401001-040102016-12-08
04546540134998NA01-0407001-040702016-12-08
04546540135018NA01-0410001-041002016-12-08
04546540138477NA01-0956101-095612016-12-08
04546540141514NA01-1531501-153152017-01-11
04546540143242NA01-1971501-197152016-12-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327300536MEDPORStryker Leibinger GmbH & Co. KGFWP2023-02-13
07613327300406MEDPORStryker Leibinger GmbH & Co. KGFWP2023-01-09
07613327300413MEDPORStryker Leibinger GmbH & Co. KGFWP2023-01-09
07613327300437MEDPORStryker Leibinger GmbH & Co. KGFWP2023-01-09
07613327300444MEDPORStryker Leibinger GmbH & Co. KGFWP2023-01-09
07613327300451MEDPORStryker Leibinger GmbH & Co. KGFWP2023-01-09
07613327300475MEDPORStryker Leibinger GmbH & Co. KGFWP2023-01-09
07613327300499MEDPORStryker Leibinger GmbH & Co. KGFWP2023-01-09
07613327300505MEDPORStryker Leibinger GmbH & Co. KGFWP2023-01-09
07613327300512MEDPORStryker Leibinger GmbH & Co. KGFWP2023-01-09
07613327300529MEDPORStryker Leibinger GmbH & Co. KGFWP2023-01-09
07613327300550MEDPORStryker Leibinger GmbH & Co. KGFWP2023-01-09
07613327300567MEDPORStryker Leibinger GmbH & Co. KGFWP2023-01-09
00815285022766Su-Por Surgical ImplantPORIFEROUS, LLCFWP2020-03-25
00815285022773Su-Por Surgical ImplantPORIFEROUS, LLCFWP2020-03-25
00815285022780Su-Por Surgical ImplantPORIFEROUS, LLCFWP2020-03-25
00815285022797Su-Por Surgical ImplantPORIFEROUS, LLCFWP2020-03-25
M724VMA11LNS1Vertical Mandibular Angle™IMPLANTECH ASSOCIATES, INC.FWP2019-05-15
M724VMA11RNS1Vertical Mandibular Angle™IMPLANTECH ASSOCIATES, INC.FWP2019-05-15
M724VMA13LNS1Vertical Mandibular Angle™IMPLANTECH ASSOCIATES, INC.FWP2019-05-15
M724VMA13RNS1Vertical Mandibular Angle™IMPLANTECH ASSOCIATES, INC.FWP2019-05-15
M724VMA7LNS1Vertical Mandibular Angle™IMPLANTECH ASSOCIATES, INC.FWP2019-05-15
M724VMA7RNS1Vertical Mandibular Angle™IMPLANTECH ASSOCIATES, INC.FWP2019-05-15
M724ACSIZNS1Anatomical Chin SizersIMPLANTECH ASSOCIATES, INC.FWP2017-10-17
M724CEACSIZNS1Conform™ Extended AnatomicalIMPLANTECH ASSOCIATES, INC.FWP2017-10-17
M724CSCSIZNS1Curvilinear Silicone Chin SizersIMPLANTECH ASSOCIATES, INC.FWP2017-10-17
M724EACSIZNS1Extended Anatomical Chin SizersIMPLANTECH ASSOCIATES, INC.FWP2017-10-17
M724FMGVSIZNS1Flowers Mandibular Glove® Sizers IMPLANTECH ASSOCIATES, INC.FWP2017-10-17
M724MPJSIZNS1Mandibular Pre Jowl® ImplantIMPLANTECH ASSOCIATES, INC.FWP2017-10-17
M724TEACSIZNS1Terino Extended Anatomical™IMPLANTECH ASSOCIATES, INC.FWP2017-10-17