FDA.reportPublic FDA data

Kyocera Medical Technologies, Inc.

Primary DI
00841523170258
Brand
Kyocera Medical Technologies, Inc.
Company
KYOCERA MEDICAL TECHNOLOGIES, INC.
Model
Tesera-k ALIF
Catalog number
2167-001-317
Device description
Unilateral 2 Hole Speed Guide, 17mm
Published
2025-08-11
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
00841523170258PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841523170258008415231702588415231702580841523170258

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
Premarket exempt
true
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

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Primary DI, Brand, Company table
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08698940971454SayanSAYAN TIBBI ALETLER PAZARLAMA SANAYI VE TICARET LIMITED SIRKETILXH2026-06-03
G4533312BT0PEAK MEDICALPeak Medical Distribution Inc.LXH2026-06-03
07613327648355PANGEAStryker GmbHLXH2026-06-02
07613327648379PANGEAStryker GmbHLXH2026-06-02
00199150077359Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-06-01
00199150077366Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-06-01
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00857915007736RaspA.M. SURGICAL, INC.LXH2026-06-01
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