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
00810111227346Scalpel 02-003872026-05-19
00810111227223SpeedMTP SelectSK692026-05-13
00810111227247SpeedMTP SelectSD342026-05-13
00810111227254SpeedMTP SelectSD332026-05-13
00810111225663X-ray App12-000012026-05-01
00810111226769ReamerSN502026-05-01
00810111226776ReamerSN512026-05-01
00810111226783ReamerSN522026-05-01
00810111227261K-Wire02-005202026-04-27
00810111224987Screwdriver02-004402026-04-15
00810111225007Screwdriver02-004422026-04-15
00810111225021Screwdriver02-004442026-04-15
00810111225069Screwdriver02-004482026-04-15
00810111225458Instrument Tray02-004822026-04-15
00810111225670Screwdriver02-005062026-04-15
00810111225687Percuplasty SuperBite Compression ScrewSC701302026-04-15
00810111225694Percuplasty SuperBite Compression ScrewSC701252026-04-15
00810111225700Percuplasty SuperBite Compression ScrewSC701202026-04-15
00810111225717Percuplasty SuperBite Compression ScrewSC701152026-04-15
00810111225724Percuplasty SuperBite Compression ScrewSC701102026-04-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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ESAM23080161STOMA®Storz am Mark GmbHFSM2025-04-30
ESAM6550401STOMA®Storz am Mark GmbHFSM2025-04-30
ESAM6551101STOMA®Storz am Mark GmbHFSM2025-04-30
ESAM23080011STOMA®Storz am Mark GmbHFSM2023-06-14
ESAM6679001STOMA®Storz am Mark GmbHFSM2023-06-14
EZPF85140000HELMUT ZEPFHelmut Zepf Medizintechnik GmbHFSM2022-12-12
EZPF85142100HELMUT ZEPFHelmut Zepf Medizintechnik GmbHFSM2022-12-12
EZPF85142200HELMUT ZEPFHelmut Zepf Medizintechnik GmbHFSM2022-12-12
EZPF85145000HELMUT ZEPFHelmut Zepf Medizintechnik GmbHFSM2022-12-12
EZPF85150000HELMUT ZEPFHelmut Zepf Medizintechnik GmbHFSM2022-12-12
EZPF85195650HELMUT ZEPFHelmut Zepf Medizintechnik GmbHFSM2022-12-12
EZPF85312070HELMUT ZEPFHelmut Zepf Medizintechnik GmbHFSM2022-12-12
EZPF85180000HELMUT ZEPFHelmut Zepf Medizintechnik GmbHFSM2022-12-09
EZPF85180010HELMUT ZEPFHelmut Zepf Medizintechnik GmbHFSM2022-12-09
EZPF85180020HELMUT ZEPFHelmut Zepf Medizintechnik GmbHFSM2022-12-09
EZPF85180030HELMUT ZEPFHelmut Zepf Medizintechnik GmbHFSM2022-12-09
EZPF85180040HELMUT ZEPFHelmut Zepf Medizintechnik GmbHFSM2022-12-09
EZPF85180050HELMUT ZEPFHelmut Zepf Medizintechnik GmbHFSM2022-12-09
EZPF85180100HELMUT ZEPFHelmut Zepf Medizintechnik GmbHFSM2022-12-09
EZPF85181000HELMUT ZEPFHelmut Zepf Medizintechnik GmbHFSM2022-12-09
EZPF85181010HELMUT ZEPFHelmut Zepf Medizintechnik GmbHFSM2022-12-09
EZPF85181030HELMUT ZEPFHelmut Zepf Medizintechnik GmbHFSM2022-12-09
EZPF85181040HELMUT ZEPFHelmut Zepf Medizintechnik GmbHFSM2022-12-09
EZPF85181050HELMUT ZEPFHelmut Zepf Medizintechnik GmbHFSM2022-12-09
EZPF85181090HELMUT ZEPFHelmut Zepf Medizintechnik GmbHFSM2022-12-09
EZPF85182000HELMUT ZEPFHelmut Zepf Medizintechnik GmbHFSM2022-12-09
EZPF85182010HELMUT ZEPFHelmut Zepf Medizintechnik GmbHFSM2022-12-09
EZPF85182030HELMUT ZEPFHelmut Zepf Medizintechnik GmbHFSM2022-12-09
EZPF85182040HELMUT ZEPFHelmut Zepf Medizintechnik GmbHFSM2022-12-09