FDA.reportPublic FDA data

NA

Primary DI
10887587066073
Brand
NA
Company
Synthes GmbH
Model
SD800.548
Catalog number
SD800548
Device description
PSI SD800.548 PEEK IMPLANT
Published
2015-09-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GXNPLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXNPlate, Cranioplasty, Preformed, Non-AlterableNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K033868000
K053199000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K033868000SYNTHES (USA) PATIENT SPECIFIC CRANIAL/CRANIOFACIAL IMPLANTSSynthes (Usa)2004-06-21GXN
K053199000SYNTHES PATIENT SPECIFIC CRANIAL/CRANIOFACIAL IMPLANTSynthes (Usa)2005-12-14GXN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10887587066073PrimaryGS10
H980SD8005480SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088758706607310887587066073

GMDN Terms#

Term, Definition table
TermDefinition
Cranial bone prosthesis, custom-madeA sterile implantable device intended to repair a defect of the cranium or mandible that is designed and constructed with specific characteristics (e.g., size, shape, material) as prescribed by a healthcare provider for a specified patient. It is typically manufactured from a three-dimensional (3-D) model based on computed tomography (CT) images and made of plastic [e.g., ultrahigh molecular weight polyethylene (UHMWPE), polyetheretherketone (PEEK)] and/or metal [e.g., titanium (Ti)]. The device may be used to repair defects due to injury, surgical intervention for tumour removal, congenital anomaly, or disease, or for cosmetic/aesthetic purposes.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
486711679
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10886982030054LCP02.108.412021084122015-09-14
10886982033079VA-LCP02.112.049021120492015-09-14
10886982042590LCP02.124.213021242132015-09-14
10886982055552NA02.221.002S02221002S2015-09-14
10886982055569NA02.221.003S02221003S2015-09-14
10886982055583NA02.221.004S02221004S2015-09-14
10886982076748NA03.221.015032210152016-12-31
10886982076762NA03.221.016032210162016-12-31
10886982076779NA03.221.017032210172016-12-31
10886982120960NA04.221.002S04221002S2015-09-14
10886982120977NA04.221.003S04221003S2015-09-14
10886982120991NA04.221.004S04221004S2015-09-14
10886982182494NA298.800.01S29880001S2015-09-14
10886982182500NA298.801.01S29880101S2015-09-14
10886982198112NA391.1033911032016-12-31
10886982198129NA391.1043911042016-12-31
10886982198136NA391.1053911052016-12-31
10886982198143NA391.1063911062016-12-31
10886982198150NA391.1073911072016-12-31
10886982198167NA391.1083911082016-12-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810188324177HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-06-09
00810188324719HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-06-09
00810188324689HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-06-03
00810188324665HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-06-01
00810188324641HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-05-28
00810188324658HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-05-28
00810188324634HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-05-27
08859751210556METICULY Patient-specific titanium mesh implantMETICULY COMPANY LIMITEDGXN2026-03-05
08859751210563METICULY Patient-specific titanium mesh implantMETICULY COMPANY LIMITEDGXN2026-03-05
08859751210570METICULY Patient-specific titanium mesh implantMETICULY COMPANY LIMITEDGXN2026-03-05
08859751216206METICULY Patient-specific titanium mesh implantMETICULY COMPANY LIMITEDGXN2026-03-05
08859751216312METICULY Patient-specific titanium mesh implantMETICULY COMPANY LIMITEDGXN2026-03-05
08859751216329METICULY Patient-specific titanium mesh implantMETICULY COMPANY LIMITEDGXN2026-03-05
08859751216336METICULY Patient-specific titanium mesh implantMETICULY COMPANY LIMITEDGXN2026-03-05
08859751216343METICULY Patient-specific titanium mesh implantMETICULY COMPANY LIMITEDGXN2026-03-05
08859751216411METICULY Patient-specific titanium mesh implantMETICULY COMPANY LIMITEDGXN2026-03-05
08859751216428METICULY Patient-specific titanium mesh implantMETICULY COMPANY LIMITEDGXN2026-03-05
08859751216435METICULY Patient-specific titanium mesh implantMETICULY COMPANY LIMITEDGXN2026-03-05
08859751216442METICULY Patient-specific titanium mesh implantMETICULY COMPANY LIMITEDGXN2026-03-05
00810007631271AccuShapeMedcadGXN2023-06-23
00810007631288AccuShapeMedcadGXN2023-06-23
00810007631295AccuShapeMedcadGXN2023-06-23
00810077248829HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2023-01-16
00810077248836HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2023-01-16
00810077248973HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2023-01-09
00810077248775HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2023-01-03
00810077248706HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2022-12-21
00810077248850HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2022-12-21
00810077248904HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2022-12-21
00810077248911HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2022-12-21