FDA.report

SportMeds Instruments

Primary DI
07630542726620
Company
Medacta International SA
Model
05.05.10.9028
Device description
Sports Med-Cannulated tibial reamer extended tray
Published
2026-01-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Regulatory Flags

DUNS number
488227125
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Identifiers

IdentifierTypeAgencyPackage quantityStatus
07630542726620PrimaryGS10

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityPackage typeContains DIDiscontinue dateStatus
07630542726620PrimaryGS10

Product Codes

CodeNameClassSpecialtyRegulationImplantMalfunction reporting
NBHAccessories, Arthroscopic1Orthopedic888.1100NEligible

Premarket Submissions

No records found.

Premarket Details

No records found.

GMDN Terms

TermDefinition
Orthopaedic surgical procedure kit, non-medicated, reusableA collection of various orthopaedic surgical instruments, dressings and the necessary materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a reusable device.

Device Sizes

No records found.

Storage And Handling

No records found.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

No records found.

Other Devices From This Company

Primary DIBrandModelCatalogPublished
07630542779244Surgical Manual Instrument03.52.10.08042026-03-24
07630542715303Orthopedic Manual Surgical Instrument01.10.10.34592025-10-08
07630542715310Orthopedic Manual Surgical Instrument01.10.10.34602025-10-08
07630542715327Orthopedic Manual Surgical Instrument01.10.10.34612025-10-08
07630542715334Orthopedic Manual Surgical Instrument01.10.10.34622025-10-22
07630542789984Surgical Manual Instrument02.12.10.31252026-03-19
07630542789991Surgical Manual Instrument02.12.10.31262026-03-19
07630542797576Surgical Manual Instrument02.12.10.31422026-03-19
07630699705486Surgical Manual Instrument02.12.10.31622026-03-19
07630699705493Surgical Manual Instrument02.12.10.31632026-03-19
07630699705509Surgical Manual Instrument02.12.10.31642026-03-19
07630699705516Surgical Manual Instrument02.12.10.31652026-03-19
07630699705523Surgical Manual Instrument02.12.10.31662026-03-19
07630542725562Surgical Manual Instrument01.10.10.11602026-03-17
07630542791482Spine Instruments03.75.10.06612026-03-13
07630971230880Surgical Manual Instrument03.51.10.02342026-03-02
07630542790799Mfinity Femoral System01.24.10.3002026-02-27
07630542790805Mfinity Femoral System01.24.10.3012026-02-27
07630542790812Mfinity Femoral System01.24.10.3022026-02-27
07630542790829Mfinity Femoral System01.24.10.3032026-02-27

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00190776417918MillenniumAvalign Technologies, Inc.NBH2026-03-23
00190776417949MillenniumAvalign Technologies, Inc.NBH2026-03-23
00190776418267MillenniumAvalign Technologies, Inc.NBH2026-03-23
B382SD18129DK0Surgical DirectSurgical Direct, Inc.NBH2026-03-09
B382SD316590Surgical DirectSurgical Direct, Inc.NBH2026-02-26
B382SD316790Surgical DirectSurgical Direct, Inc.NBH2026-02-26
B382SD9156321000Surgical DirectSurgical Direct, Inc.NBH2026-02-26
00190776416386MillenniumAvalign Technologies, Inc.NBH2026-02-16
04055207068243VERTEBRISRichard Wolf GmbHNBH2026-02-10
04055207069691NARichard Wolf GmbHNBH2026-02-10
04055207069707NARichard Wolf GmbHNBH2026-02-10
04055207069714NARichard Wolf GmbHNBH2026-02-10
04055207069721NARichard Wolf GmbHNBH2026-02-10
04055207069738NARichard Wolf GmbHNBH2026-02-10
04055207069745NARichard Wolf GmbHNBH2026-02-10
B382SD181290Surgical DirectSurgical Direct, Inc.NBH2026-02-06
10748426142719Arthrex®Microtek Medical LLCNBH2026-02-02
00888867516144Arthrex®ARTHREX, INC.NBH2026-01-28
00888867516168Arthrex®ARTHREX, INC.NBH2026-01-28
07630542703683SportMeds InstrumentsMedacta International SANBH2026-01-21
00812231034170ZEOSSANTA BARBARA IMAGING SYSTEMS, INC.NBH2026-01-19
00812231034941ZEOSSANTA BARBARA IMAGING SYSTEMS, INC.NBH2026-01-19
00198506087622ELMED INCORPORATEDELMED INCORPORATEDNBH2026-01-16
04055207069790NARichard Wolf GmbHNBH2026-01-14
04055207069806NARichard Wolf GmbHNBH2026-01-14
04055207069813NARichard Wolf GmbHNBH2026-01-14
04055207069820NARichard Wolf GmbHNBH2026-01-14
04055207069837NARichard Wolf GmbHNBH2026-01-14
04055207069851NARichard Wolf GmbHNBH2026-01-14
06974940307045endophixSuzhou Endophix Co., Ltd.NBH2025-12-19