FDA.reportPublic FDA data

endophix

Primary DI
06974940306857
Brand
endophix
Company
Suzhou Endophix Co., Ltd.
Model
MS-1529-1
Published
2026-03-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HWJAwl

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWJAwlOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06974940306857PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06974940306857069749403068576974940306857

GMDN Terms#

Term, Definition table
TermDefinition
Joint prosthesis implantation kit, reusableA collection of surgical instruments used for cutting and forming bone to allow the implantation of a joint prosthesis. The instruments include various metallic and/or plastic reusable devices (e.g., retractors, rods, clamps, drills, pins, saws, guides, cutting blocks) that are specific to the joint of application (e.g., hip, knee, shoulder, ankle, or elbow); the implant(s) is not included. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
620899345
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06974940307236endophixMS-3107-022026-06-23
06974940307243endophixMS-31082026-06-23
06974940307830endophixMS-20032026-06-23
06974940307878endophixMS-2025-122026-06-23
06974940305188endophixMS-2025PS-62026-04-28
06974940305195endophixMS-2025PS-72026-04-28
06974940305201endophixMS-2025PS-82026-04-28
06974940305218endophixMS-2025PS-92026-04-28
06974940305225endophixMS-2025PS-102026-04-28
06974940305232endophixMS-2025PS-112026-04-28
06974940305249endophixMS2025PW-62026-04-28
06974940305256endophixMS2025PW-82026-04-28
06974940305263endophixMS2025PW-102026-04-28
06974940305270endophixMS2025PW-122026-04-28
06974940305454endophixMS-1120N2026-04-28
06974940305461endophixMS-1128N2026-04-28
06974940305478endophixMS-1128-1N2026-04-28
06974940305485endophixMS-1135N2026-04-28
06974940305492endophixMS-1150N2026-04-28
06974940305508endophixMS-1165N2026-04-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199150076482Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HWJ2026-08-03
00199150076499Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HWJ2026-08-03
00840606191586Overwatch PCFSPINAL ELEMENTS, INC.HWJ2026-07-31
00763000879556MSB Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HWJ2026-07-20
00763000675028n/aMEDTRONIC SOFAMOR DANEK, INC.HWJ2026-07-19
18257200051175PROVIEWOrthofix US LLCHWJ2026-07-17
18257200163571PILLAR SA TiOrthofix US LLCHWJ2026-07-17
18257200163588PILLAR SA TiOrthofix US LLCHWJ2026-07-17
18257200163595PILLAR SA TiOrthofix US LLCHWJ2026-07-17
B8034609130ORTHOMEDORTHO-MED, INC.HWJ2026-07-16
B8034609140ORTHOMEDORTHO-MED, INC.HWJ2026-07-16
B8034609150ORTHOMEDORTHO-MED, INC.HWJ2026-07-16
B8034609160ORTHOMEDORTHO-MED, INC.HWJ2026-07-16
B8034803030ORTHOMEDORTHO-MED, INC.HWJ2026-07-16
B8034803360ORTHOMEDORTHO-MED, INC.HWJ2026-07-16
B8034803370ORTHOMEDORTHO-MED, INC.HWJ2026-07-16
B8034803380ORTHOMEDORTHO-MED, INC.HWJ2026-07-16
B8034803390ORTHOMEDORTHO-MED, INC.HWJ2026-07-16
B8034803400ORTHOMEDORTHO-MED, INC.HWJ2026-07-16
B8034803410ORTHOMEDORTHO-MED, INC.HWJ2026-07-16
00857915007767IM Nail AwlA.M. SURGICAL, INC.HWJ2026-06-10
00840311245376Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.HWJ2026-04-30
08800322758137Anyplus ll Spinal Fixation SystemGS Medical Co., Ltd.HWJ2026-04-21
00860015151308EnFix Instrument Kit - CompleteTETROUS, INC.HWJ2026-02-24
00887868287473Trinica ALP Anterior Lumbar Plate SystemHighridge Medical, LLCHWJ2025-11-12
07640375234773SCARLET AL-T INSTRUMENTATIONSpineArt SAHWJ2025-11-10
08059386744338Orthopaedic Surgical InstrumentsCITIEFFE SRLHWJ2025-11-06
00763000674410n/aMEDTRONIC SOFAMOR DANEK, INC.HWJ2025-10-26
09120129291507Awl, Curved, CannulatedI.T.S. GmbHHWJ2025-10-21
09120129291514Awl TrocarI.T.S. GmbHHWJ2025-10-21