FDA.reportPublic FDA data

Instrument Tray

Primary DI
00810111225281
Brand
Instrument Tray
Company
Treace Medical Concepts, Inc.
Model
NK22
Device description
Lapiplasty System Tray and Instrumentation
Published
2026-03-30
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
FSMTray, Surgical, Instrument
FZXGuide, Surgical, Instrument
HWNInstrument, Compression
HWWCountersink
HXWBender
HXXScrewdriver
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1
FZXGuide, Surgical, InstrumentGeneral, Plastic Surgery1
HWNInstrument, CompressionOrthopedic1
HWWCountersinkOrthopedic1
HXWBenderOrthopedic1
HXXScrewdriverOrthopedic1
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810111225281PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810111225281008101112252818101112252810810111225281

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
054808082
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
00810111228527Drill Guide02-006302026-09-21
00810111224680TMC PSI Cut Guide SystemPSI-02-003862025-05-22
00810111224697TMC PSI Cut Guide SystemPSI-02-003852025-05-22
00810111223447TMC PSI Cut Guide SystemNK232024-11-14
00810111223454TMC PSI Cut Guide SystemNK242024-11-14
00810111223478TMC PSI Cut Guide SystemNK262024-11-14
00810111223553TMC PSI Cut Guide SystemPSI-02-002332024-11-15
00810111223560TMC PSI Cut Guide SystemPSI-02-002322024-11-15
00810111223577TMC PSI Cut Guide SystemPSI-02-002312024-11-15
00810111223584TMC PSI Cut Guide SystemPSI-02-002302024-11-15
00810111223621TMC PSI Cut Guide SystemNK272024-11-14
00810111222723TMC PSI Cut Guide SystemPSI-02-001632024-03-11
00810111222730TMC PSI Cut Guide SystemPSI-02-001622024-03-11
00810111222259TMC PSI Cut Guide SystemNK152023-11-17
00810111222266TMC PSI Cut Guide SystemPSI-01-2029-0212023-11-17
00810111222273TMC PSI Cut Guide SystemPSI-01-2229-0212023-11-17
00810111222280TMC PSI Cut Guide SystemPSI-01-2129-0212023-11-17
00810111222297TMC PSI Cut Guide SystemPSI-01-2329-0212023-11-17
00810111222327TMC PSI Cut Guide SystemPSI-06-1032-0142023-11-17
00810111222358TMC PSI Cut Guide SystemPSI-02-1610-0062023-11-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190376733470CONTOUR3DALPHATEC SPINE, INC.FSM2026-09-25
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
10886982345462VOLTSynthes GmbHHXX2026-09-25
10886982350633VOLTSynthes GmbHFZX2026-09-25
10886982350640VOLTSynthes GmbHFZX2026-09-25
10886982350657VOLTSynthes GmbHFZX2026-09-25
10886982350664VOLTSynthes GmbHFZX2026-09-25
10886982350671VOLTSynthes GmbHFZX2026-09-25
10886982350688VOLTSynthes GmbHFZX2026-09-25
10886982351098VOLTSynthes GmbHFZX2026-09-25
10886982351104VOLTSynthes GmbHFZX2026-09-25
10886982351111VOLTSynthes GmbHFZX2026-09-25
10886982351128VOLTSynthes GmbHFZX2026-09-25
10886982351135VOLTSynthes GmbHFZX2026-09-25
10886982351142VOLTSynthes GmbHFZX2026-09-25
10886982351692VOLTSynthes GmbHFZX2026-09-25
10886982357182VOLTSynthes GmbHFZX2026-09-25
10886982357335VOLTSynthes GmbHHWN2026-09-25
10886982357342VOLTSynthes GmbHHWN2026-09-25
10886982357359VOLTSynthes GmbHHWN2026-09-25