FDA.reportPublic FDA data

Drill Guide

Primary DI
00810111228527
Brand
Drill Guide
Company
Treace Medical Concepts, Inc.
Model
02-00630
Device description
Drill Guide and Template
Published
2026-09-21
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
FZXGuide, Surgical, Instrument
HWTTemplate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZXGuide, Surgical, InstrumentGeneral, Plastic Surgery1
HWTTemplateOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810111228527PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810111228527008101112285278101112285270810111228527

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
054808082
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
00810111228367Elevator02-005552026-11-05
00810111227872Pin02-005642026-10-16
00810111228428Instrument Tray02-006212026-10-16
00810111228480Retractor02-006262026-10-16
00810111228671Cut Guide02-006372026-10-16
00810111228541Drill Tack02-005392026-10-15
00810111227971Pin02-005712026-10-12
00810111227988Pin02-005722026-10-12
00810111227919BROACH02-005602026-09-30
00810111227926BROACH02-005592026-09-30
00810111227933BROACH02-005582026-09-30
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00817438028779N/AOmega Surgical Instruments IncFZX2026-11-05
00713864000047DJO SURGICALEncore Medical, L.P.FZX2026-11-04
00889024713840G7® TM Acetabular SystemZimmer, Inc.HWT2026-11-03
00889024713857G7® TM Acetabular SystemZimmer, Inc.HWT2026-11-03
00889024713864G7® TM Acetabular SystemZimmer, Inc.HWT2026-11-03
00889024713871G7® TM Acetabular SystemZimmer, Inc.HWT2026-11-03
08809974816158AnyPlus®GS Medical Co., Ltd.FZX2026-11-03
10603295555643INHANCEDEPUY ORTHOPAEDICS, INC.HWT2026-11-03
03700569679262Newclip InstrumentsNEWCLIP TECHNICSFZX2026-10-30
04260056885877InterSpace® Hip Mold Trial Short StemOSARTIS GmbHHWT2026-10-29
04260056885891InterSpace® Hip Mold Trial Short StemOSARTIS GmbHHWT2026-10-29
04260056885914InterSpace® Hip Mold Trial Short StemOSARTIS GmbHHWT2026-10-29
04260056885938InterSpace® Hip Mold Trial Long StemOSARTIS GmbHHWT2026-10-29
04260056885952InterSpace® Hip Mold Trial Long StemOSARTIS GmbHHWT2026-10-29
04260056885976InterSpace® Hip Mold Trial Long StemOSARTIS GmbHHWT2026-10-29
04260056885990InterSpace® Hip Mold Trial Head 42 mmOSARTIS GmbHHWT2026-10-29
04260056886010InterSpace® Hip Mold Trial Head 48 mmOSARTIS GmbHHWT2026-10-29
04260056886034InterSpace® Hip Mold Trial Head 52 mmOSARTIS GmbHHWT2026-10-29
04260056886058InterSpace® Hip Mold Trial Head 56 mmOSARTIS GmbHHWT2026-10-29
04260056886072InterSpace® Hip Mold Trial Head 60 mmOSARTIS GmbHHWT2026-10-29
04260056886096InterSpace® Knee Mold Trial Femoral Component XSOSARTIS GmbHHWT2026-10-29
04260056886119InterSpace® Knee Mold Trial Femoral Component SOSARTIS GmbHHWT2026-10-29
04260056886133InterSpace® Knee Mold Trial Femoral Component MOSARTIS GmbHHWT2026-10-29
04260056886157InterSpace® Knee Mold Trial Femoral Component LOSARTIS GmbHHWT2026-10-29
04260056886171InterSpace® Knee Mold Trial Femoral Component XLOSARTIS GmbHHWT2026-10-29
04260056886195InterSpace® Knee Mold Trial Tibial Component XSOSARTIS GmbHHWT2026-10-29
04260056886218InterSpace® Knee Mold Trial Tibial Component SOSARTIS GmbHHWT2026-10-29
04260056886232InterSpace® Knee Mold Trial Tibial Component MOSARTIS GmbHHWT2026-10-29
04260056886256InterSpace® Knee Mold Trial Tibial Component LOSARTIS GmbHHWT2026-10-29
04260056886270InterSpace® Knee Mold Trial Tibial Component XLOSARTIS GmbHHWT2026-10-29