FDA.reportPublic FDA data

C3® ACPS

Primary DI
03663136001944
Brand
C3® ACPS
Company
SPINEVISION
Model
C1-P1 0365
Device description
36.5 mm plate with SLS
Published
2015-10-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K012881000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K012881000C3 ANTERIOR CERVICAL PLATE SYSTEMSpine Vision, Inc.2001-11-26KWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03663136001944PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03663136001944036631360019443663136001944

GMDN Terms#

Term, Definition table
TermDefinition
Spinal fixation plate, non-bioabsorbableA small, implantable, non-customized sheet of solid material intended to be attached to the spine with screws for spinal immobilization; it 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
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
390377518
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03663136001869C3® ACPSC1-P1 02652015-10-15
03663136001876C3® ACPSC1-P1 0265N12015-10-15
03663136001883C3® ACPSC1-P1 02902015-10-15
03663136001913C3® ACPSC1-P1 0315N12015-10-15
03663136002095C3® ACPSC1-P2 0540N12015-10-15
03663136002170C3® ACPSC1-P3 06902015-10-15
03663136002262C3® ACPSC1-P4 08902015-10-15
03663136002309C3® ACPSC1-P4 10502015-10-15
03663136019482C3® ACPSC1-L1 03902015-10-15
03663136019574C3® ACPSC1-L3 05702015-10-15
03663136001821C3® ACPSC1-P1 02152015-10-15
03663136001838C3® ACPSC1-P1 0215N12015-10-15
03663136001845C3® ACPSC1-P1 02402015-10-15
03663136001852C3® ACPSC1-P1 0240N12015-10-15
03663136001890C3® ACPSC1-P1 0290N12015-10-15
03663136001920C3® ACPSC1-P1 03402015-10-15
03663136001937C3® ACPSC1-P1 0340N12015-10-15
03663136001951C3® ACPSC1-P1 0365N12015-10-15
03663136001968C3® ACPSC1-P1 03902015-10-15
03663136001982C3® ACPSC1-P2 04152015-10-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197157081515ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081522ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081539ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081546ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081553ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081560ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081577ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081584ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081591ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081607ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081614ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081621ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081638ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081645ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081652ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081669ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081676ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081683ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081690ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081706ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081713ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081720ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081737ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081744ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081751ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081768ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081775ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081782ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081799ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081805ZAVATION SCREWZavation LLCKWP2026-06-04