FDA.reportPublic FDA data

Active™

Primary DI
B6788210600
Brand
Active™
Company
NEXUS SPINE, L.L.C.
Model
821060
Device description
2 Level Active Plate Caddy
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
KWQAppliance, Fixation, Spinal Intervertebral Body

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2

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
B678821060Direct MarkingHIBCC0
B6788210600PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Spinal fixation plate, non-bioabsorbableA small implantable sheet of solid material that is attached to the spine with screws for spinal immobilization and is made of a material that is not chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is typically used to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities (e.g., during anterior/posterior cervical, anterior/posterior lumbar, thoracolumbar, and occipital fixation procedures).

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
B678520297S0PressON™520297S2026-07-10
B678520298S0PressON™520298S2026-07-10
B678520299S0PressON520299S2026-07-10
B678520300S0PressON™520300S2026-07-10
B678520301S0PressON520301S2026-07-10
B678520302S0PressON™520302S2026-07-10
B678520303S0PressON520303S2026-07-10
B678520304S0PressON™520304S2026-07-10
B678520305S0PressON520305S2026-07-10
B678520306S0PressON™520306S2026-07-10
B678520485S0PressON Pedicle Screw System520485S2026-07-10
B678520486S0PressON Pedicle Screw System520486S2026-07-10
B678520487S0PressON Pedicle Screw System520487S2026-07-10
B678520488S0PressON Pedicle Screw System520488S2026-07-10
B678520489S0PressON Pedicle Screw System520489S2026-07-10
B678520490S0PressON Pedicle Screw System520490S2026-07-10
B678520491S0PressON Pedicle Screw System520491S2026-07-10
B678520492S0PressON Pedicle Screw System520492S2026-07-10
B678520493S0PressON Pedicle Screw System520493S2026-07-10
B678520494S0PressON Pedicle Screw System520494S2026-07-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190376778372InvictusALPHATEC SPINE, INC.FSM2026-08-19
00190376778396InvictusALPHATEC SPINE, INC.FSM2026-08-19
00840493426426RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-18
00840493426433RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-18
00840493426440RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-18
00840493426457RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-18
00840493426464RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-18
00840493426471RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-18
00840493426488RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-18
00840493426495RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-18
00840493426501RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-18
00840493426518RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-18
00840493426525RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-18
00840493426532RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-18
00840493426549RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-18
00840493426556RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-18
00840493426563RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-18
00840493426570RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-18
00840493426587RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-18
00840493426594RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-18
00840493426600RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-18
00840493426617RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-18
00840493426624RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-18
00840493426631RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-18
08800322759516Torque Limiting HandleGS Medical Co., Ltd.FSM2026-08-18
10806378116810ACUMEDAcumed LLCFSM2026-08-18
10806378116827ACUMEDAcumed LLCFSM2026-08-18
10806378116841ACUMEDAcumed LLCFSM2026-08-18
10806378116858ACUMEDAcumed LLCFSM2026-08-18
G8791062750DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDFSM2026-08-18