FDA.reportPublic FDA data

PreView™

Primary DI
B67882108120
Brand
PreView™
Company
NEXUS SPINE, L.L.C.
Model
821081.2
Device description
"Medfix Cloward Blade Retractor Angled, 7.5"" (19cm) 20mm Wide Blade"
Published
2022-02-28
Public version status
Update
Distribution status
Not 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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2

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
B67882108120PrimaryHIBCC0

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
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B6785209110PressON Pedicle Screw System5209112026-09-04
B6785209120PressON Pedicle Screw System5209122026-09-04
B6785209130PressON Pedicle Screw System5209132026-09-04
B6785209140PressON Pedicle Screw System5209142026-09-04
B6785209150PressON Pedicle Screw System5209152026-09-04
B6785209160PressON Pedicle Screw System5209162026-09-04
B6785209170PressON Pedicle Screw System5209172026-09-04
B6785209180PressON Pedicle Screw System5209182026-09-04
B6785209190PressON Pedicle Screw System5209192026-09-04
B6785209200PressON Pedicle Screw System5209202026-09-04
B6785209210PressON Pedicle Screw System5209212026-09-04
B6785209220PressON Pedicle Screw System5209222026-09-04
B6785209230PressON Pedicle Screw System5209232026-09-04
B6785209240PressON Pedicle Screw System5209242026-09-04
B6785209250PressON Pedicle Screw System5209252026-09-04
B6785209260PressON Pedicle Screw System5209262026-09-04
B6785209270PressON Pedicle Screw System5209272026-09-04
B6785209280PressON Pedicle Screw System5209282026-09-04
B6785209290PressON Pedicle Screw System5209292026-09-04
B6785209300PressON Pedicle Screw System5209302026-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810017916184SABER-XA, Expandable Spacer, 37x28mm,13mm, (12°)ELEVATION SPINE, INC.KWQ2026-10-01
00810017916214SABER-XA, Anterior Plate, 37Wx13HELEVATION SPINE, INC.KWQ2026-10-01
10888857598256Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598263Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598270Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598287Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598294Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598300Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598317Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598324Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598331Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598348Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598355Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598362Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598379Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598386Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598393Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598409Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598416Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598423Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598430Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598447Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598454Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598461Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598478Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598485Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598492Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598508Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598515Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598522Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24