FDA.reportPublic FDA data

RapidSorb

Primary DI
10887587064178
Brand
RapidSorb
Company
Synthes GmbH
Model
851.691.01S
Catalog number
85169101S
Device description
1.5MM RAPID RESORB ORBTL FL PL W/BENDING TEMPLATE/35MM-STER
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
JEYPLATE, BONE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JEYPlate, BoneDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K030069000
K062789000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K030069000SYNTHES POLY (L-LACTIDE-CO-GLYCOLIDE) RESORBABLE FIXATION SYSTEMSynthes (Usa)2003-04-08JEY
K062789000SYNTHES (USA) RAPID RESORBABLE FIXATION SYSTEMSynthes (Usa)2007-02-27JEY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10887587064178PrimaryGS10
H98085169101S0SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088758706417810887587064178

GMDN Terms#

Term, Definition table
TermDefinition
Craniofacial fixation plate, bioabsorbableA small, implantable, non-customized sheet of firm material designed to be attached with screws to craniofacial bone (including the maxilla and/or mandible) to bridge and stabilize a fracture gap or craniotomy flap, and/or cover a burr hole. It is made of bioabsorbable materials (e.g., degradable polymer) and is available in a variety of designs (e.g., Y-plate, curved plate, mesh-panel, burr hole cover). Instruments intended to facilitate implantation (e.g., driver), or bioabsorbable plate fixation implants (i.e., bone screws), may be included with the plate.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature043 Degrees Celsius
Handling Environment Temperature0110 Degrees Fahrenheit
Special Storage Condition, Specify00.
Storage Environment Temperature5 Degrees Celsius25 Degrees Celsius
Storage Environment Temperature41 Degrees Fahrenheit77 Degrees Fahrenheit

Contacts#

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

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10886982239297NA519.51519512017-02-20
10886982195937NA357.2223572222017-02-20
10886982238115NA511.9045119042016-12-31
10886982239358NA519.53519532016-12-31
10886982249043NA60.550.011605500112017-02-20
10886982249104NA60.550.016605500162017-02-20
10886982249135NA60.550.020605500202017-02-20
10886982249142NA60.550.021605500212017-02-20
10886982254917NA690.5946905942017-02-20
10886982362797NASD03.111.915SD031119152026-08-26
10886982362803NASD03.111.916SD031119162026-08-26
10886982362810NASD03.111.917SD031119172026-08-26
10886982362827NASD03.111.918SD031119182026-08-26
10886982362834NASD03.111.919SD031119192026-08-26
10886982362988NASD312.030SD3120302026-08-26
10886982362995NASD312.031SD3120312026-08-26
10886982363008NASD312.032SD3120322026-08-26
10886982363015NASD312.033SD3120332026-08-26
10887587078496NASD03.503.037SD035030372026-08-26
10887587078595NASD03.501.444SD035014442026-08-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04046826486228MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJEY2026-07-29
04046826531478MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJEY2026-07-29
04046826531485MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJEY2026-07-29
04046826561741MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJEY2026-07-29
04046826531454MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJEY2026-07-28
00888118154620LEVEL ONE CMFKLS-Martin L.P.JEY2026-07-21
00888118154637LEVEL ONE CMFKLS-Martin L.P.JEY2026-07-21
07613327694482DELTAStryker Leibinger GmbH & Co. KGJEY2026-07-21
07613327694499DELTAStryker Leibinger GmbH & Co. KGJEY2026-07-21
04046826346812MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJEY2026-06-25
04046826416676MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJEY2026-06-25
04046826542337MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJEY2026-06-25
04046826543655MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJEY2026-06-25
04046826552473MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJEY2026-06-25
00888118126528LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2020-04-22
05420060381041TruMatchMaterialise NVJEY2020-03-16
10888118113600LEVEL ONE CMFKLS-Martin L.P.JEY2017-10-20
10888118113617LEVEL ONE CMFKLS-Martin L.P.JEY2017-10-20
05420060380150TruMatchMaterialise NVJEY2017-08-31
05420060380174TruMatchMaterialise NVJEY2017-08-31
05420060381034TruMatchMaterialise NVJEY2017-08-31
05420060351112ProPlan CMFMaterialise NVJEY2016-09-15
05420060351013ProPlan CMFMaterialise NVJEY2016-09-13
05420060351020ProPlan CMFMaterialise NVJEY2016-09-13
05420060351044ProPlan CMFMaterialise NVJEY2016-09-13
05420060351051ProPlan CMFMaterialise NVJEY2016-09-13
05420060351068ProPlan CMFMaterialise NVJEY2016-09-13
05420060351075ProPlan CMFMaterialise NVJEY2016-09-13
00888118001825LEVEL ONE CMFKLS-Martin L.P.JEY2016-03-24
00888118001870LEVEL ONE CMFKLS-Martin L.P.JEY2016-03-24