FDA.reportPublic FDA data

OrthoMedFlex

Primary DI
M7161031120
Brand
OrthoMedFlex
Company
ORTHOMEDFLEX LLC
Model
103112
Catalog number
103-112
Device description
Notched Posterior Plane Probe
Published
2020-06-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
M7161031120PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments. It may be used for the following applications: 1) to hold/align/fix bone preparation instruments, prosthesis, or prosthesis component; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface between prosthesis components. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
034442726
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
M7161011020OrthoMedFlex101-1021011022016-08-30
M7161011250OrthoMedFlex101-125101-1252016-08-29
M7161011260OrthoMedFlex101-126101-1262016-08-29
M7161011340OrthoMedFlex101-134101-1342016-08-30
M7161011430OrthoMedFlex, LLC101-143101-1432017-09-19
M716101164280OrthoMedFlex101-164-28101-164-282016-08-29
M716101164360OrthoMedFlex101-164-36101-164-362016-08-29
M7161011710OrthoMedFlex101-171101-1712016-08-29
M7161012260OrthoMedFlex101-226101-2262016-09-01
M7161012290OrthoMedFlex101229101-2292017-03-07
M7161012400OrthoMedFlex101240101-2402017-10-03
M7161012430OrthoMedFlex101-243101-2432021-06-24
M7161013010OrthoMedFlex101-301101-3012016-08-31
M7161013020OrthoMedFlex101-302101-3022016-08-31
M7161013040OrthoMedFlex, LLC101-304101-3042017-04-25
M7161013190OrthoMedFlex101-319101-3192016-08-29
M7161013190210OrthoMedFlex101319021101-319-0212017-02-23
M7161013310OrthoMedFlex, LLC101-331101-3312017-09-19
M7161013510OrthoMedFlex101-351101-3512016-08-31
M7161013520OrthoMedFlex, LLC101-352101-3522017-04-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840606188128Ventana ASPINAL ELEMENTS, INC.LXH2026-07-13
B382SD9141791400Surgical DirectSurgical Direct, Inc.LXH2026-07-13
B382SD9142211000Surgical DirectSurgical Direct, Inc.LXH2026-07-13
00199150075034Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-10
07640177820907Neo Medical Pedicle screw kitNeo Medical SALXH2026-07-10
00840286860093Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.LXH2026-07-09
00840286860109Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.LXH2026-07-09
00840286860116Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.LXH2026-07-09
00190446924838Arsenal FootTrilliant Surgical, LLCLXH2026-06-24
00190446948469Arsenal FootTrilliant Surgical, LLCLXH2026-06-24
00190446948476Arsenal FootTrilliant Surgical, LLCLXH2026-06-24
00840067212189TrellOss®-A SANEXXT SPINE, LLCLXH2026-06-24
00840067212196TrellOss®-A SANEXXT SPINE, LLCLXH2026-06-24
00840067212202TrellOss®-A SANEXXT SPINE, LLCLXH2026-06-24
00840067212219TrellOss®-A SANEXXT SPINE, LLCLXH2026-06-24
00840067212226TrellOss®-A SANEXXT SPINE, LLCLXH2026-06-24
00840067212233TrellOss®-A SANEXXT SPINE, LLCLXH2026-06-24
00840067212240TrellOss®-A SANEXXT SPINE, LLCLXH2026-06-24
00840067212257TrellOss®-A SANEXXT SPINE, LLCLXH2026-06-24
00840067212264TrellOss®-A SANEXXT SPINE, LLCLXH2026-06-24
00840067212271TrellOss®-A SANEXXT SPINE, LLCLXH2026-06-24
00840067212288TrellOss®-A SANEXXT SPINE, LLCLXH2026-06-24
00840067212295TrellOss®-A SANEXXT SPINE, LLCLXH2026-06-24
00840067212301TrellOss®-A SANEXXT SPINE, LLCLXH2026-06-24
00840067212318TrellOss®-A SANEXXT SPINE, LLCLXH2026-06-24
00889929072752NEXXT MATRIXX® Stand Alone ALIF SystemNEXXT SPINE, LLCLXH2026-06-24
00889929072769NEXXT MATRIXX® Stand Alone ALIF SystemNEXXT SPINE, LLCLXH2026-06-24
00889929072776NEXXT MATRIXX® Stand Alone ALIF SystemNEXXT SPINE, LLCLXH2026-06-24
00889929072783NEXXT MATRIXX® Stand Alone ALIF SystemNEXXT SPINE, LLCLXH2026-06-24
04046826486631Stern-a-Fix Sternal Closure SystemMedicon eG. Chirurgiemechaniker-GenossenschaftLXH2026-06-24