FDA.reportPublic FDA data

Kyocera Medical Technologies, Inc.

Primary DI
00841523177899
Brand
Kyocera Medical Technologies, Inc.
Company
KYOCERA MEDICAL TECHNOLOGIES, INC.
Model
Tesera-K SC
Catalog number
3061-011-000
Device description
Tesera-k Cervical Interbody Instrument Case
Published
2025-08-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841523177899PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841523177899008415231778998415231778990841523177899

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
116995646
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
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
00724995323592V. MuellerSTERIS Deutschland GmbHLXH2026-09-25
00840606186223ALIF Disc PrepSPINAL ELEMENTS, INC.LXH2026-09-25
00840606186230ALIF Disc PrepSPINAL ELEMENTS, INC.LXH2026-09-25
00840606186261ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00840606186278ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00840606186285ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00840606187381ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00843193112699Prodisc C InstrumentCentinel Spine, LLCLXH2026-09-25
00843193112705Prodisc C InstrumentCentinel Spine, LLCLXH2026-09-25
07630040795166Surgical Manual InstrumentMedacta International SALXH2026-09-25
07630542792359Surgical Manual InstrumentMedacta International SALXH2026-09-25
20845854655501Argo KnotlessConmed CorporationLXH2026-09-25
20845854655518Argo KnotlessConmed CorporationLXH2026-09-25
00810130207541MSIModern Surgical Instruments LLCLXH2026-09-24
00810130207558MSIModern Surgical Instruments LLCLXH2026-09-24
00840606185929PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606185936PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606186773PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606186780PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606187237PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606187244PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606187251PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00885556854778Cadence Total Ankle SystemSmith & Nephew, Inc.LXH2026-09-24
07899258601670Orthopedic InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDALXH2026-09-24
B7685215250Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2026-06-19
B7683434130Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2026-04-23
B7685216220Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-13
B7685111560Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-03
B768521135180Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-03
B7685216060Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-03