FDA.reportPublic FDA data

PreView™

Primary DI
B76882108330
Brand
PreView™
Company
NEXUS SPINE, L.L.C.
Model
821083.3
Device description
Medfix 14 x 35mm Micro-Blunt Blade, Blue
Published
2022-02-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
B76882108330PrimaryHIBCC0

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).

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length35Millimeter
Width14Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
028137605
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
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
10888857598164Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598171Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598188Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598195Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598201Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598218Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598225Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598232Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598249Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
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