FDA.reportPublic FDA data

ADAPT

Primary DI
07613327312430
Brand
ADAPT
Company
Stryker Leibinger GmbH & Co. KG
Model
0101-2000
Catalog number
0101-2000
Device description
PC Set
Published
2018-11-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HSBROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
OLOOrthopedic stereotaxic instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSBRod, Fixation, Intramedullary And AccessoriesOrthopedic2
OLOOrthopedic Stereotaxic InstrumentNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K181848000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181848000ADAPT for Gamma3, Gamma3Stryker GmbH2018-10-12OLO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327312430PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327312430076133273124307613327312430

GMDN Terms#

Term, Definition table
TermDefinition
Medical image management systemA computerized image data management system designed to electronically receive, collect, store, and display a broad range of medical imaging/video data (non-dedicated), and to distribute the data within or between healthcare facilities to facilitate data analysis, organization, reporting, and sharing (e.g., teaching). The system consists of combined hardware (e.g., network switch, controller) and server/client software intended to relay image data from a broad range of imaging/audiovisual devices (e.g., endoscopic camera, ultrasound imaging system, radiography digital imaging system) to off-the-shelf devices [e.g., monitors, personal computers (PC’s)].

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
316153956
Device count
1
Lot or batch
true
Serial number
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
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00840493423173RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423180RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423197RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423203RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423210RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423227RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423234RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423241RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423258RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423265RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423272RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423289RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423296RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423302RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423319RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423326RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423333RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423340RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423357RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423364RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423371RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423388RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423395RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423401RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423418RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423425RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423432RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423449RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423456RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08