FDA.reportPublic FDA data

Indus®

Primary DI
00190361001966
Brand
Indus®
Company
SPINEFRONTIER, INC.
Model
IM71045-05
Device description
Invue, Cervical Plate, Four Level, 85mm
Published
2016-04-15
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
K093776000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K093776000INDUS ANTERIOR CERVICAL PLATE SYSTEMSpinefrontier, Inc.2010-03-26KWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190361001966PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190361001966001903610019661903610019660190361001966

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
Length85Millimeter
Width16.5Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(866)914-7717customerservice@spinefrontier.com

Regulatory Flags#

DUNS number
002003243
Device count
1
DM exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190361000983Indus®01-71002-172016-04-15
00190361000990Indus®01-71002-192016-04-15
00190361001003Indus®01-71002-212016-04-15
00190361001010Indus®01-71002-232016-04-15
00190361001027Indus®01-71002-252016-04-15
00190361001034Indus®01-71002-272016-04-15
00190361001041Indus®01-71002-292016-04-15
00190361001058Indus®01-71002-312016-04-15
00190361001065Indus®01-71002-332016-04-15
00190361001072Indus®01-71002-352016-04-15
00190361001089Indus®01-710032016-04-15
00190361001096Indus®01-71004-332016-04-15
00190361001102Indus®01-71004-352016-04-15
00190361001119Indus®01-71004-372016-04-15
00190361001126Indus®01-71004-392016-04-15
00190361001133Indus®01-71004-412016-04-15
00190361001140Indus®01-71004-432016-04-15
00190361001157Indus®01-71004-452016-04-15
00190361001164Indus®01-71004-472016-04-15
00190361001171Indus®01-71004-492016-04-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810017913664Saber-C Body (PT), 12x15x7 6 deg.ELEVATION SPINE, INC.KWQ2026-06-05
00810017914609Saber-C Plate, 14x17x6 12 deg.ELEVATION SPINE, INC.KWQ2026-06-05
00810017914616Saber-C Plate, 14x17x7 12 deg.ELEVATION SPINE, INC.KWQ2026-06-05
00810017914623Saber-C Plate, 14x17x8 12 deg.ELEVATION SPINE, INC.KWQ2026-06-05
00810017915354Saber-C, Spike Driver 5-7, MedialELEVATION SPINE, INC.KWQ2026-06-05
00810017915361Saber-C, Spike Driver 5-7, LateralELEVATION SPINE, INC.KWQ2026-06-05
00810017915378Saber-C, Spike Driver 8-9, MedialELEVATION SPINE, INC.KWQ2026-06-05
00810017915385Saber-C, Spike Driver 8-9, LateralELEVATION SPINE, INC.KWQ2026-06-05
00840283407949VyPlate™VY SPINE LLCKWQ2026-06-05
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00840493422602RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-05
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00840493422664RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-05
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00840493422688RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-05
00840493422695RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-05
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00840493422725RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-05
00840493422732RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-05
00840493422749RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-05
00840493422756RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-05
00840493422763RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-05
00840493422770RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-05
00840493422787RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-05
00840493422794RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-05