FDA.reportPublic FDA data

PAC PLATE™* ANTERIOR CERVICAL PLATE SYSTEM

Primary DI
00846468023843
Brand
PAC PLATE™* ANTERIOR CERVICAL PLATE SYSTEM
Company
Pioneer Surgical Technology, Inc.
Model
20-235-D
Catalog number
20-235-D
Device description
TWO LEVEL, DYNAMIC PLATE
Published
2015-11-30
Public version status
Update
Distribution status
Not 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
K083663000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K083663000PACPPioneer Surgical Technology2009-02-25KWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00846468004262PrimaryGS10
00846468023843PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00846468004262008464680042628464680042620846468004262
00846468023843008464680238438464680238430846468023843

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

Contacts#

Phone, Email table
PhoneEmail
+1(386)418-8888labeling@rtix.com
+1(906)226-9909labeling@resolvesurg.com
+1(906)226-9909regulatory@exalta.com

Regulatory Flags#

DUNS number
793384496
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840298703685CODA™ Anterior Cervical Plate System58-202230010S2022-30-010S2023-06-28
00840298703708CODA™ Anterior Cervical Plate System58-202230014S2022-30-014S2023-06-28
00840298701445CODA™ Anterior Cervical Plate System58-102201010S1022-01-010S2023-06-26
00840298701452CODA™ Anterior Cervical Plate System58-102201012S1022-01-012S2023-06-26
00840298701469CODA™ Anterior Cervical Plate System58-102201014S1022-01-014S2023-06-26
00840298701476CODA™ Anterior Cervical Plate System58-102201016S1022-01-016S2023-06-26
00840298701490CODA™ Anterior Cervical Plate System58-102201020S1022-01-020S2023-06-26
00840298701506CODA™ Anterior Cervical Plate System58-102201022S1022-01-022S2023-06-26
00840298701520CODA™ Anterior Cervical Plate System58-102201026S1022-01-026S2023-06-26
00840298701537CODA™ Anterior Cervical Plate System58-102201028S1022-01-028S2023-06-26
00840298701544CODA™ Anterior Cervical Plate System58-102201030S1022-01-030S2023-06-26
00840298701568CODA™ Anterior Cervical Plate System58-102202026S1022-02-026S2023-06-26
00840298701582CODA™ Anterior Cervical Plate System58-102202030S1022-02-030S2023-06-26
00840298701599CODA™ Anterior Cervical Plate System58-102202032S1022-02-032S2023-06-26
00840298701605CODA™ Anterior Cervical Plate System58-102202034S1022-02-034S2023-06-26
00840298701612CODA™ Anterior Cervical Plate System58-102202036S1022-02-036S2023-06-26
00840298701629CODA™ Anterior Cervical Plate System58-102202038S1022-02-038S2023-06-26
00840298701636CODA™ Anterior Cervical Plate System58-102202040S1022-02-040S2023-06-26
00840298701643CODA™ Anterior Cervical Plate System58-102202042S1022-02-042S2023-06-26
00840298701650CODA™ Anterior Cervical Plate System58-102202044S1022-02-044S2023-06-26

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