FDA.reportPublic FDA data

Kyocera Medical Technologies, Inc.

Primary DI
00841523141111
Brand
Kyocera Medical Technologies, Inc.
Company
KYOCERA MEDICAL TECHNOLOGIES, INC.
Model
S 158
Catalog number
1058-316-311
Device description
NSA Cervical Cage, 16mm X 13.5mm X 11mm, 12° Lordosis, 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
00841523141111PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841523141111008415231411118415231411110841523141111

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
B084AC1141605070Anterior Cervical IBFDKEOSODP2024-02-09
B084AC1141606070Anterior Cervical IBFDKEOSODP2024-02-09
B084AC1141607070Anterior Cervical IBFDKEOSODP2024-02-09
B084AC1141608070Anterior Cervical IBFDKEOSODP2024-02-09
B084AC1141609070Anterior Cervical IBFDKEOSODP2024-02-09
B084AC1141610070Anterior Cervical IBFDKEOSODP2024-02-09
B084AC1141611070Anterior Cervical IBFDKEOSODP2024-02-09
B084AC1141612070Anterior Cervical IBFDKEOSODP2024-02-09
B084AC1161805000Anterior Cervical IBFDKEOSODP2024-02-09
B084AC1161805040Anterior Cervical IBFDKEOSODP2024-02-09
B084AC1161805070Anterior Cervical IBFDKEOSODP2024-02-09
B084AC1161806000Anterior Cervical IBFDKEOSODP2024-02-09
B084AC1161806040Anterior Cervical IBFDKEOSODP2024-02-09
B084AC1161806070Anterior Cervical IBFDKEOSODP2024-02-09
B084AC1161807000Anterior Cervical IBFDKEOSODP2024-02-09
B084AC1161807040Anterior Cervical IBFDKEOSODP2024-02-09
B084AC1161807070Anterior Cervical IBFDKEOSODP2024-02-09
B084AC1161808000Anterior Cervical IBFDKEOSODP2024-02-09
B084AC1161808040Anterior Cervical IBFDKEOSODP2024-02-09
B084AC1161808070Anterior Cervical IBFDKEOSODP2024-02-09
B084AC1161809000Anterior Cervical IBFDKEOSODP2024-02-09
B084AC1161809040Anterior Cervical IBFDKEOSODP2024-02-09
B084AC1161809070Anterior Cervical IBFDKEOSODP2024-02-09
B084AC1161810000Anterior Cervical IBFDKEOSODP2024-02-09
B084AC1161810040Anterior Cervical IBFDKEOSODP2024-02-09
B084AC1161810070Anterior Cervical IBFDKEOSODP2024-02-09
B084AC1161811000Anterior Cervical IBFDKEOSODP2024-02-09
B084AC1161811040Anterior Cervical IBFDKEOSODP2024-02-09
B084AC1161811070Anterior Cervical IBFDKEOSODP2024-02-09
B084AC1161812000Anterior Cervical IBFDKEOSODP2024-02-09