FDA.reportPublic FDA data

PreView™

Primary DI
B6788210520
Brand
PreView™
Company
NEXUS SPINE, L.L.C.
Model
821052
Device description
Fixed Angle Double Barrel Drill Guide 5 deg - Cervical
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
KWQAppliance, Fixation, Spinal Intervertebral Body
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K062371000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K062371000PREVIEW ANTERIOR CERVICAL PLATE SYSTEMAlphaspine, Inc.2006-12-04KWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B678821052Direct MarkingHIBCC0
B6788210520PrimaryHIBCC0

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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04052536085552neon3Ulrich GmbH & Co. KGLXH2026-05-28
10888857596894OZARK Cervical Plate SystemVB Spine LLCKWQ2026-05-28
M7403030028Discectomy SetSPINEOLOGY INC.LXH2026-05-28
M7403030029Discectomy SetSPINEOLOGY INC.LXH2026-05-28
M7403030030Discectomy SetSPINEOLOGY INC.LXH2026-05-28
M7403030031Discectomy SetSPINEOLOGY INC.LXH2026-05-28
M7403030032Discectomy SetSPINEOLOGY INC.LXH2026-05-28
M7403030033Discectomy SetSPINEOLOGY INC.LXH2026-05-28
M7403030034Discectomy SetSPINEOLOGY INC.LXH2026-05-28
M7403030035Discectomy SetSPINEOLOGY INC.LXH2026-05-28
M7403030036Discectomy SetSPINEOLOGY INC.LXH2026-05-28
M7403030059Discectomy SetSPINEOLOGY INC.LXH2026-05-28
M7403030060Discectomy SetSPINEOLOGY INC.LXH2026-05-28
00810166522816Expanding InnovationsEXPANDING INNOVATIONS, INC.LXH2026-05-27
00810166522823Expanding InnovationsEXPANDING INNOVATIONS, INC.LXH2026-05-27
00810166522830Expanding InnovationsEXPANDING INNOVATIONS, INC.LXH2026-05-27
00810166522847Expanding InnovationsEXPANDING INNOVATIONS, INC.LXH2026-05-27
00810166522854Expanding InnovationsEXPANDING INNOVATIONS, INC.LXH2026-05-27
00810166522861Expanding InnovationsEXPANDING INNOVATIONS, INC.LXH2026-05-27
00810166522878Expanding InnovationsEXPANDING INNOVATIONS, INC.LXH2026-05-27
00889929072424Matrixx SystemNEXXT SPINE, LLCLXH2026-05-27
07640187918809Straight reamer handleMPS Micro Precision Systems AGLXH2026-05-27
00840354204958Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354204965Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354204972Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354204989Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354204996Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205009Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205016Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205023Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07