FDA.reportPublic FDA data

Kyocera Medical Technologies, Inc.

Primary DI
00841523141302
Brand
Kyocera Medical Technologies, Inc.
Company
KYOCERA MEDICAL TECHNOLOGIES, INC.
Model
S 158
Catalog number
1058-416-307
Device description
NSA Cervical Cage, 16mm X 13.5mm X 7mm, Anatomic, T3
Published
2019-01-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
ODPIntervertebral Fusion Device With Bone Graft, Cervical
OVEIntervertebral Fusion Device With Integrated Fixation, Cervical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ODPIntervertebral Fusion Device With Bone Graft, CervicalOrthopedic2
OVEIntervertebral Fusion Device With Integrated Fixation, CervicalOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K153250000
K182007000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K153250000Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies2016-03-16OVE
K182007000Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies2018-12-07OVD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841523141302PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841523141302008415231413028415231413020841523141302

GMDN Terms#

Term, Definition table
TermDefinition
Metallic spinal interbody fusion cageA device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of metal [e.g., titanium (Ti)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be included with the device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
116995646
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841523183944Kyocera Medical Technologies, Inc.Initia T33535-851-0122026-08-21
00841523183999Kyocera Medical Technologies, Inc.Tesera-k ALIF2167-001-5112026-08-21
00841523184002Kyocera Medical Technologies, Inc.Tesera-k ALIF2167-001-5132026-08-21
00841523184019Kyocera Medical Technologies, Inc.Tesera-k ALIF2167-001-5152026-08-21
00841523184026Kyocera Medical Technologies, Inc.Tesera-k ALIF2167-001-5172026-08-21
00841523184033Kyocera Medical Technologies, Inc.Tesera-k ALIF2167-001-5192026-08-21
00841523184040Kyocera Medical Technologies, Inc.Tesera-k ALIF2167-001-5212026-08-21
00841523185337Kyocera Medical Technologies, Inc.Tesera-K-SC3061-011-0162026-08-21
00841523183081Kyocera Medical Technologies, Inc.Tesera-K XL2173-001-0032026-08-07
00841523183746Kyocera Medical Technologies, Inc.Tesera-K XL3073-005-0002026-08-07
00841523185030Kyocera Medical Technologies, Inc.Tesera-K XL2173-018-1082026-08-07
00841523185047Kyocera Medical Technologies, Inc.Tesera-K XL2173-018-1102026-08-07
00841523185054Kyocera Medical Technologies, Inc.Tesera-K XL2173-018-1122026-08-07
00841523185061Kyocera Medical Technologies, Inc.Tesera-K XL2173-018-1142026-08-07
00841523185078Kyocera Medical Technologies, Inc.Tesera-K XL2173-018-1162026-08-07
00841523185092Kyocera Medical Technologies, Inc.Tesera-K XL2173-018-2102026-08-07
00841523185108Kyocera Medical Technologies, Inc.Tesera-K XL2173-018-2122026-08-07
00841523185139Kyocera Medical Technologies, Inc.Tesera-K XL2173-022-1082026-08-07
00841523185146Kyocera Medical Technologies, Inc.Tesera-K XL2173-022-1102026-08-07
00841523185153Kyocera Medical Technologies, Inc.Tesera-K XL2173-022-1122026-08-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800322776391QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776407QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776414QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776421QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776438QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776445QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776452QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776469QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776476QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776483QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776490QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776506QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776513QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776520QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776537QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776544QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776551QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776568QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776575QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776582QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776599QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776605QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776612QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776629QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776636QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776643QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776650QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776667QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776674QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776681QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18