FDA.reportPublic FDA data

Active™

Primary DI
B6788210390
Brand
Active™
Company
NEXUS SPINE, L.L.C.
Model
821039
Device description
Cervical Tray Fully Assembled - Active System
Published
2022-02-28
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
FSMTray, Surgical, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K073500000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K073500000ACTIVE ANTERIOR CERVICAL PLATE SYSTEMSanacor2008-07-03KWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B678821039Direct MarkingHIBCC0
B6788210390PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
028137605
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B6785220130Tranquil-L™5220132021-12-17
B6785220140Tranquil-L™5220142021-12-17
B6785220150Tranquil-L™5220152021-12-17
B6785220160Tranquil-L™5220162021-12-17
B6785220170Tranquil-L™5220172021-12-17
B6785220180Tranquil-L™5220182021-12-17
B6785220190Tranquil-L™5220192021-12-17
B6785220200Tranquil-L™5220202021-12-17
B6785220210Tranquil-L™5220212021-12-17
B6785220220Tranquil-L™5220222021-12-17
B6785220120Tranquil-L™5220122021-12-17
B6785229040Tranquil-L™5229042021-12-17
B6785229050Tranquil-L™5229052021-12-17
B6785229060Tranquil-L™5229062021-12-17
B6785229070Tranquil-L™5229072021-12-17
B6785229080Tranquil-L™5229082021-12-17
B6785229090Tranquil-L™5229092021-12-17
B6785229100Tranquil-L™5229102021-12-17
B6785229110Tranquil-L™5229112021-12-17
B6785229120Tranquil-L™5229122021-12-17

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Primary DI, Brand, Company table
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07613327652765TPXSTRYKER CORPORATIONFSM2026-03-25
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07613327631876RPSSTRYKER CORPORATIONFSM2025-10-01
07613327681741N/ASTRYKER CORPORATIONFSM2025-09-03
ESAM23080001STOMA®Storz am Mark GmbHFSM2025-04-30
ESAM23080161STOMA®Storz am Mark GmbHFSM2025-04-30
ESAM6550401STOMA®Storz am Mark GmbHFSM2025-04-30
ESAM6551101STOMA®Storz am Mark GmbHFSM2025-04-30
ESAM23080011STOMA®Storz am Mark GmbHFSM2023-06-14
ESAM6679001STOMA®Storz am Mark GmbHFSM2023-06-14
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07630894802973APTUSMedartis AGFSM2023-02-24
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