FDA.reportPublic FDA data

Kyocera Medical Technologies, Inc.

Primary DI
00841523133185
Brand
Kyocera Medical Technologies, Inc.
Company
KYOCERA MEDICAL TECHNOLOGIES, INC.
Model
S 140
Catalog number
1140-445-013
Device description
ACP, Ø4.5mm x 13mm, Revision Fixed Angle Screw, Self-Tapping
Published
2016-11-21
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
KWQAppliance, Fixation, Spinal Intervertebral Body

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152193000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152193000Renovis Anterior Cervical Plate SystemRenovis Surgical Technologies, Inc.2015-09-25KWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841523133185PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841523133185008415231331858415231331850841523133185

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

Regulatory Flags#

DUNS number
116995646
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841523146871Kyocera Medical Technologies, Inc.S 1803180-004-0012025-04-08
00841523146888Kyocera Medical Technologies, Inc.S 1803180-004-0022025-04-08
00841523146901Kyocera Medical Technologies, Inc.S 1803180-005-0012025-04-08
00841523146918Kyocera Medical Technologies, Inc.S 1803180-005-0022025-04-08
00841523146932Kyocera Medical Technologies, Inc.S 1803180-006-0002025-04-08
00841523146949Kyocera Medical Technologies, Inc.S 1803180-006-0012025-04-08
00841523146956Kyocera Medical Technologies, Inc.S 1803180-007-0002025-04-08
00841523137060Kyocera Medical Technologies, Inc.S 1281063-730-6172019-01-17
00841523181360Kyocera Medical Technologies, Inc.Tesera-k PL2171-001-0012026-05-26
00841523181681Kyocera Medical Technologies, Inc.Tesera-k PL2171-221-1072026-05-26
00841523181698Kyocera Medical Technologies, Inc.Tesera-k PL2171-221-1082026-05-26
00841523181704Kyocera Medical Technologies, Inc.Tesera-k PL2171-221-1092026-05-26
00841523181711Kyocera Medical Technologies, Inc.Tesera-k PL2171-221-1102026-05-26
00841523181728Kyocera Medical Technologies, Inc.Tesera-k PL2171-221-1112026-05-26
00841523181735Kyocera Medical Technologies, Inc.Tesera-k PL2171-221-1122026-05-26
00841523181742Kyocera Medical Technologies, Inc.Tesera-k PL2171-221-1132026-05-26
00841523181759Kyocera Medical Technologies, Inc.Tesera-k PL2171-221-1142026-05-26
00841523181766Kyocera Medical Technologies, Inc.Tesera-k PL2171-221-1152026-05-26
00841523181773Kyocera Medical Technologies, Inc.Tesera-k PL2171-221-1162026-05-26
00841523181780Kyocera Medical Technologies, Inc.Tesera-k PL2171-229-1072026-05-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000859404CD Horizon™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-07-18
00763000910365CD Horizon™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-07-18
20763000910376CD Horizon™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-07-18
00840493424712RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424729RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
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00840493424750RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
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00840493424873RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424880RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424897RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
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00840493424927RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424934RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424941RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424958RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424965RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
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