FDA.reportPublic FDA data

Kyocera Medical Technologies, Inc.

Primary DI
00841523181704
Brand
Kyocera Medical Technologies, Inc.
Company
KYOCERA MEDICAL TECHNOLOGIES, INC.
Model
Tesera-k PL
Catalog number
2171-221-109
Device description
Tk PL Modular Trial, 11mm X 22mm, 7°, 9mm (PLIF)
Published
2026-05-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
00841523181704PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841523181704008415231817048415231817040841523181704

GMDN Terms#

Term, Definition table
TermDefinition
General internal orthopaedic fixation system implantation kitA collection of instruments and devices intended to be used for the placement of an internal orthopaedic fixation system into or onto all types of bones (e.g., bones of limbs, spine, pelvis, or craniomaxillofacial). It is a non-dedicated device that includes various metallic and/or plastic reusable devices [e.g., retractors, rods, clamps, drills, pins, saws, screwdrivers, guides, trials, impactors] intended to be used for the implantation of any type of internal orthopaedic fixation system; the implant(s) is not included. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
116995646
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
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
07630894827723AVENGERMedartis AGLXH2026-10-13
07630894827730AVENGERMedartis AGLXH2026-10-13
07630894827747AVENGERMedartis AGLXH2026-10-13
00190776434762MillenniumAvalign Technologies, Inc.LXH2026-10-12
00850080243176OSTEOROD Delivery SystemBONE SOLUTIONS, INC.LXH2026-10-12
00889795150264APEX 3D Total Ankle Replacement SystemParagon 28, Inc.LXH2026-10-12
00724995225148NASTERIS CORPORATIONLXH2025-03-31
00196449010219A.L.P.S. mvX™Tyber Medical, LLCLXH2023-12-15
00196449012800A.L.P.S. mvX™Tyber Medical, LLCLXH2023-12-15
B0842002000400Keos Lumbar InstrumentKEOSLXH2023-02-07
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B0842002000480Keos Lumbar InstrumentKEOSLXH2023-02-07
B0842002000490Keos Lumbar InstrumentKEOSLXH2023-02-07
B0842002000500Keos Lumbar InstrumentKEOSLXH2023-02-07
B0842002000600Keos Lumbar InstrumentKEOSLXH2023-02-07
B0842002000610Keos Lumbar InstrumentKEOSLXH2023-02-07
B0842002000620Keos Lumbar InstrumentKEOSLXH2023-02-07
B0842002000630Keos Lumbar InstrumentKEOSLXH2023-02-07
B0842002000640Keos Lumbar InstrumentKEOSLXH2023-02-07
B0842002000650Keos Lumbar InstrumentKEOSLXH2023-02-07
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B0842002000670Keos Lumbar InstrumentKEOSLXH2023-02-07
B0842002000680Keos Lumbar InstrumentKEOSLXH2023-02-07
B0842002000690Keos Lumbar InstrumentKEOSLXH2023-02-07