FDA.reportPublic FDA data

SynPOR

Primary DI
10887587026244
Brand
SynPOR
Company
Synthes GmbH
Model
08.510.640S
Catalog number
08510640S
Device description
SYNPOR SMOOTH ORBITAL FLOOR PLATE 24MM/0.8MM THK-STERILE
Published
2015-09-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FTLMesh, surgical, polymeric
FTMMesh, surgical
GWOPlate, cranioplasty, preformed, alterable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTLMesh, Surgical, PolymericGeneral, Plastic Surgery2
FTMMesh, SurgicalGeneral, Plastic Surgery2
GWOPlate, Cranioplasty, Preformed, AlterableNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K051879000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K051879000SYNTHES (USA) POROUS POLYETHYLENE IMPLANTSSynthes (Usa)2005-10-05FTM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10887587026244PrimaryGS10
H98008510640S0SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088758702624410887587026244

GMDN Terms#

Term, Definition table
TermDefinition
Polyethylene craniofacial tissue reconstructive materialA sterile implantable device intended to support, contour, and provide structure for the craniofacial anatomy (i.e., head and face including the chin, cheeks, nose, eye sockets and ears) during reconstructive and plastic surgery procedures. It is typically a high-density polyethylene (PE) material with an interconnecting pore structure that supports tissue ingrowth. The device is available in blocks, sheets, wedges and spheres that can be cut by the surgeon to meet the patient's specific needs. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
486711679
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810112599275TriLEAP04.900.251049002512025-03-20
00810112599169TriLEAP04.900.240049002402025-03-18
00810112599763TriLEAP03.900.407039004072025-03-18
00810112599176TriLEAP04.900.241049002412025-03-17
00810112599183TriLEAP04.900.242049002422025-03-17
00810112599190TriLEAP04.900.243049002432025-03-17
00810112599206TriLEAP04.900.244049002442025-03-17
00810112599213TriLEAP04.900.245049002452025-03-17
00810112599220TriLEAP04.900.246049002462025-03-17
00810112599237TriLEAP04.900.247049002472025-03-17
00810112599244TriLEAP04.900.248049002482025-03-17
00810112599251TriLEAP04.900.249049002492025-03-17
00810112599268TriLEAP04.900.250049002502025-03-17
00810112592467TriLeap Lower Etremity Anatomic Plating System60.900.307609003072024-02-23
00810112592528TriLeap Lower Extremity Anatomic Plating03.900.311039003112024-02-23
00810112592566TriLeap Lower Etremity Anatomic Plating System03.900.332039003322024-02-23
00810112597035TriLeap Lower Extremity Plating System04.900.057049000572024-02-21
00810112596793TriLEAP04.900.151049001512026-02-19
00810112597202TriLEAP04.913.035049130352026-02-19
00810112597219TriLEAP04.913.040049130402026-02-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00810228570595CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-10-15
00810228570601FUSION SKULL IMPLANTKELYNIAM GLOBAL, INC.GWO2026-10-15
00810228570540CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-10-07
00810228570557CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-10-07
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00810228570526FUSION SKULL IMPLANTKELYNIAM GLOBAL, INC.GWO2026-10-01
00810228570533CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-10-01
00810228570465FUSION SKULL IMPLANTKELYNIAM GLOBAL, INC.GWO2026-09-28
00810228570472CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-09-28
00810228570489CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-09-28
00810228570496FUSION SKULL IMPLANTKELYNIAM GLOBAL, INC.GWO2026-09-28
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00810228570458CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-09-21
00810228570373CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-09-18
00810228570380CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-09-18
00810228570397FUSION SKULL IMPLANTKELYNIAM GLOBAL, INC.GWO2026-09-18
00810228570403CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-09-18
00810228570410FUSION SKULL IMPLANTKELYNIAM GLOBAL, INC.GWO2026-09-18
00810228570427FUSION SKULL IMPLANTKELYNIAM GLOBAL, INC.GWO2026-09-18
00810228570434FUSION SKULL IMPLANTKELYNIAM GLOBAL, INC.GWO2026-09-18
00810228570441FUSION SKULL IMPLANTKELYNIAM GLOBAL, INC.GWO2026-09-18
00810228570137CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-08-17
00810228570144FUSION SKULL IMPLANTKELYNIAM GLOBAL, INC.GWO2026-08-17
00810228570151CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-08-17