FDA.report

endophix

Primary DI
06974940305348
Brand
endophix
Company
Suzhou Endophix Co., Ltd.
Model
MS-1555PLK
Published
2025-12-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
MBIFastener, Fixation, Nondegradable, Soft Tissue

Product Code Classifications

CodeDeviceSpecialtyClass
MBIFastener, Fixation, Nondegradable, Soft TissueOrthopedic2

Premarket Submissions

SubmissionSupplement
K231002000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K231002000Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot PK-P suture anchor, Javelot PK-P suture anchor (Knotless), Javelot PK-L suture anchor (Knotless)Suzhou Endophix Co., Ltd.2023-06-07MBI

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
06974940305348PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
06974940305348069749403053486974940305348

GMDN Terms

TermDefinition
Tendon/ligament bone anchor, non-bioabsorbableA non-bioabsorbable device designed to be implanted into bone for the attachment of tendons/ligaments/soft tissues either directly or via a suture attached to the device; typically used in arthroscopic or open surgical procedures. This device is available in various designs and sizes and is made of a material that cannot be chemically degraded or absorbed via natural body processes [e.g., titanium (Ti)].

Sterilization Methods

Method

Regulatory Flags

DUNS number
620899345
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
06974940306727endophixMS-15252026-03-03
06974940306758endophixMS-15292026-03-03
06974940306772endophixMS-1535T2026-03-03
06974940306857endophixMS-1529-12026-03-03
06974940306864endophixMS-1529-22026-03-03
06974940306918endophixMS-1525-32026-03-03
06974940307007endophixMS-1529-32026-03-03
06974940307021endophixMS-1525-12026-03-03
06974940307038endophixMS-1525-22026-03-03
06974940307045endophixMS-430620S2025-12-19
06974940307052endophixMS-430820S2025-12-19
06974940307069endophix MS-430840S2025-12-19
06974940307076endophix MS-430860S2025-12-19
06974940307083endophixMS-431020S2025-12-19
06974940307090endophixMS-431050S2025-12-19
06974940306321endophixMS-32022025-12-12
06974940306352endophixMS-32032025-12-12
06974940306369endophixMS-32042025-12-12
06974940306468endophixMS-32052025-12-12
06974940306604endophixMS-32062025-12-12

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