FDA.reportPublic FDA data

SIMPLEX/SARAL

Primary DI
00852647007764
Brand
SIMPLEX/SARAL
Company
PARAMOUNT SURGICALS, INC.
Model
322-1024
Catalog number
322-1024
Device description
1 LEVEL CERVICAL PLATE 24 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
KWQAppliance, Fixation, Spinal Intervertebral Body

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K070335000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K070335000SIMPLEX CERVICAL FIXATION SYSTEMPisharodi Surgicals, Inc.2007-04-16KWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852647007764PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852647007764008526470077648526470077640852647007764

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
Length24Millimeter

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

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00840493423449RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-08
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