FDA.reportPublic FDA data

RapidSorb

Primary DI
10887587057255
Brand
RapidSorb
Company
Synthes GmbH
Model
530.551
Catalog number
530551
Device description
RAPIDSORB IPS POWER DRIVE UNIT
Published
2016-10-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HBWFASTENER, PLATE, CRANIOPLASTY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HBWFastener, Plate, CranioplastyNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K141385000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141385000DEPUY SYNTHES INJECTABLE POLYMER SYSTEM (IPS)Depuy Synthes Companies of Johnson & Johnson2015-03-27HBW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10887587057255PrimaryGS10
H9805305510SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088758705725510887587057255

GMDN Terms#

Term, Definition table
TermDefinition
Bone/joint surgical power tool motor, electricA hand-held, electrically-powered component of a surgical power tool assembly designed to convert electrical energy into a non-dedicated mechanical energy to perform a variety of surgical procedures such as drilling or sawing of bones and tough tissues; it is not dedicated to dental procedures. It is designed to accept a motorless handpiece component/attachment (not included) and it is not intended to directly accept an endpiece (e.g., drill bit, saw blade). It may be a micro or macro style device, be cannulated to permit use of a guidewire, include a rechargeable battery, and might be operated with a hand- or foot-switch. This is a reusable device.

Contacts#

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

Regulatory Flags#

DUNS number
486711679
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10887587078540NASD03.501.442SD035014422026-07-29
10886982362179NASD03.043.006SD030430062026-07-24
10887587078557NASD03.503.067SD035030672026-07-24
10887587078564NASD03.503.072SD035030722026-07-24
10705034712307NA03.604.002036040022016-12-31
10705034712802NA03.606.011036060112016-12-31
10705034714592NA03.613.012036130122016-12-31
10705034767819VentroFix304.8343048342016-12-31
10705034768939NA314.0643140642016-12-31
10705034768960Click'X314.0673140672016-12-31
10705034768977Click'X314.0683140682016-12-31
10705034768984Click'X314.0693140692016-12-31
10705034769646NA328.0263280262016-12-31
10705034772608NA388.3643883642016-12-31
10705034775401NA389.2883892882016-12-31
10705034777375NA394.5853945852016-12-31
20705034764051NA292.0202920202019-08-29
00863176000317FIBULINKFGS-1100FGS11002020-03-26
00863176000324FIBULINKFGS-1300FGS13002020-03-26
00863176000300FIBULINKFGS-1000FGS10002017-06-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327694482DELTAStryker Leibinger GmbH & Co. KGHBW2026-07-21
07613327694499DELTAStryker Leibinger GmbH & Co. KGHBW2026-07-21
08806390889049Leforte Neuro System Bone PlateJeil Medical CorporationHBW2023-11-30
07613327543032DELTAStryker Leibinger GmbH & Co. KGHBW2020-12-15
08809595972837Neuro Plating SystemOSTEONIC CO.,Ltd.HBW2019-12-30
08809595972868Neuro Plating SystemOSTEONIC CO.,Ltd.HBW2019-12-30
08809595972882Neuro Plating SystemOSTEONIC CO.,Ltd.HBW2019-12-30
08809595972707Neuro Plating SystemOSTEONIC CO.,Ltd.HBW2019-02-13
08809595972714Neuro Plating SystemOSTEONIC CO.,Ltd.HBW2019-02-13
08809595972721Neuro Plating SystemOSTEONIC CO.,Ltd.HBW2019-02-13
07613327423648DELTAStryker Leibinger GmbH & Co. KGHBW2018-05-22
07613327423655DELTAStryker Leibinger GmbH & Co. KGHBW2018-05-22
07613327423662DELTAStryker Leibinger GmbH & Co. KGHBW2018-05-22
07613327177534DELTAStryker Leibinger GmbH & Co. KGHBW2018-04-16
08809265151982Leforte Neuro System Bone PlateJeil Medical CorporationHBW2018-04-12
08806390862271Leforte Neuro System Bone PlateJeil Medical CorporationHBW2018-02-26
08806390861953Leforte Neuro System Bone PlateJeil Medical CorporationHBW2018-01-22
08806390855150Sterile NS SystemJeil Medical CorporationHBW2017-10-13
08806390855174Sterile NS SystemJeil Medical CorporationHBW2017-10-13
08806390855198Sterile NS SystemJeil Medical CorporationHBW2017-10-13
08806390855211Sterile NS SystemJeil Medical CorporationHBW2017-10-13
08806390854641Sterile NS SystemJeil Medical CorporationHBW2017-09-20
07613327177510DELTAStryker Leibinger GmbH & Co. KGHBW2017-03-09
07613327177541DELTAStryker Leibinger GmbH & Co. KGHBW2017-03-09
10887587057262RapidSorbSynthes GmbHHBW2016-10-07
10887587057279RapidSorbSynthes GmbHHBW2016-10-07
10887587061573RapidSorbSynthes GmbHHBW2016-10-07
10887587061580RapidSorbSynthes GmbHHBW2016-10-07
10887587061597RapidSorbSynthes GmbHHBW2016-10-07
10887587061603RapidSorbSynthes GmbHHBW2016-10-07