FDA.reportPublic FDA data

UNIMAX

Primary DI
00852647007405
Brand
UNIMAX
Company
PARAMOUNT SURGICALS, INC.
Model
114-310
Catalog number
114-310
Device description
VERTICAL PLATE STANDARD 31 MM
Published
2016-11-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MNHOrthosis, Spondylolisthesis Spinal Fixation
MNIOrthosis, Spinal Pedicle Fixation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNHOrthosis, Spondylolisthesis Spinal FixationOrthopedic2
MNIOrthosis, Spinal Pedicle FixationOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K014302000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K014302000UNIVERSAL MULTIAXIS (UNIMAX) PEDICLE SCREW SYSTEMPisharodi Surgicals, Inc.2002-03-29MNH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852647007405PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852647007405008526470074058526470074050852647007405

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system, non-sterileAn assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Non-sterile disposable devices associated with implantation may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length31Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
956-541-1220param@paramountsurgicals.com

Regulatory Flags#

DUNS number
015483156
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00852647007009UNIMAX110-5540110-55402016-11-01
00852647007016UNIMAX110-5545110-55452016-11-01
00852647007023UNIMAX110-5550110-55502016-11-01
00852647007030UNIMAX110-6040110-60402016-11-01
00852647007047UNIMAX110-6045110-60452016-11-01
00852647007054UNIMAX110-6050110-60502016-11-01
00852647007061UNIMAX110-6540110-65402016-11-01
00852647007078UNIMAX110-6545110-65452016-11-01
00852647007085UNIMAX110-6550110-65502016-11-01
00852647007092UNIMAX110-7040110-70402016-11-01
00852647007108UNIMAX110-7045110-70452016-11-01
00852647007115UNIMAX110-7050110-70502016-11-01
00852647007122UNIMAX112-425112-4252016-11-01
00852647007139UNIMAX112-425B112-425B2016-11-01
00852647007146UNIMAX112-450112-4502016-11-01
00852647007153UNIMAX112-450B112-450B2016-11-01
00852647007160UNIMAX112-475112-4752016-11-01
00852647007177UNIMAX112-475B112-475B2016-11-01
00852647007184UNIMAX112-500112-5002016-11-01
00852647007191UNIMAX112-500B112-500B2016-11-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03700780634583Erisma®-LPCLARIANCEMNH2026-05-28
03700780634583Erisma®-LPCLARIANCEMNI2026-05-28
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07613153143741XIA STAINLESS STEELStryker CorporationMNH2015-09-14
07613153143758XIA STAINLESS STEELStryker CorporationMNI2015-09-14
07613153143758XIA STAINLESS STEELStryker CorporationMNH2015-09-14
07613153143765XIA STAINLESS STEELStryker CorporationMNI2015-09-14
07613153143765XIA STAINLESS STEELStryker CorporationMNH2015-09-14
07613153045670XIA IStryker CorporationMNH2014-12-08
07613153045700XIA IStryker CorporationMNH2014-12-08
07613153045700XIA IStryker CorporationMNI2014-12-08
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07613153045793XIA IIStryker CorporationMNI2014-12-08
07613153045793XIA IIStryker CorporationMNH2014-12-08
07613153045847XIA IIStryker CorporationMNH2014-12-08
07613153045847XIA IIStryker CorporationMNI2014-12-08
07613153045854XIA IIStryker CorporationMNH2014-12-08
07613153045861XIA IIStryker CorporationMNH2014-12-08
07613153045861XIA IIStryker CorporationMNI2014-12-08
07613153045878XIA IIStryker CorporationMNI2014-12-08