FDA.reportPublic FDA data

Fixone All Suture Anchor

Primary DI
08800039100847
Brand
Fixone All Suture Anchor
Company
AJU PHARM. CO., LTD.
Model
FAM-7615802fg
Device description
Fixone All suture anchor consists of one “fix Suture” and one,two or three non-absorbable Sutures. The non-absorbable suture is manufactured from UHMWPE. They are pre-loaded on a handled insertion device. This device isprovided sterile, for single use only. This device is medical device. Prescription use only.
Published
2025-01-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MBIFastener, Fixation, Nondegradable, Soft Tissue

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MBIFastener, Fixation, Nondegradable, Soft TissueOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K222423000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222423000Fixone All Suture AnchorAju Pharm Co., Ltd.2023-03-23MBI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800039100847PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800039100847088000391008478800039100847

GMDN Terms#

Term, Definition table
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 table
Method

Regulatory Flags#

DUNS number
963422810
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800039100021Fixone Biocomposite AnchorBAB-45003ch2025-01-06
08800039100038Fixone Biocomposite AnchorBAB-55002dh2025-01-06
08800039100045Fixone Biocomposite AnchorBAB-55003ch2025-01-06
08800039100083Fixone Biocomposite AnchorKAB-55001ca2025-01-06
08800039100212Fixone Biocomposite Interference ScrewIAB-80025a2025-01-06
08800039100229Fixone Biocomposite Interference ScrewIAB-90025a2025-01-06
08800039100236Joinix Cannula SystemACS60072a2025-01-06
08800039100335Fixone Biocomposite AnchorSAL-30002i2025-01-06
08800039100380Fixone Biocomposite AnchorNAB-47502d2025-01-06
08800039100465Fixone All Suture AnchorFAS-1652803jw2025-01-06
08800039100502Fixone All Suture AnchorFAF-24615802ig2025-01-06
08800039100571Fixone Hybrid AnchorKAP-47501ca2025-01-06
08800039100601Fixone Hybrid AnchorKAP-55001ca2025-01-06
08800039100618Fixone InstrumentFixone.I.B-Awl450ak2025-01-06
08800039100625Fixone InstrumentFixone.I.B-Awl550ak2025-01-06
08800039100632Fixone InstrumentFixone.I.B-A/T450a2025-01-06
08800039100649Fixone InstrumentFixone.I.B-A/T550a2025-01-06
08800039100656Fixone InstrumentFixone.I.S-D/B3002025-01-06
08800039100663Fixone InstrumentFixone.I.S-D/G3002025-01-06
08800039100670Fixone InstrumentFixone.I.SL-D3002025-01-06

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Primary DI, Brand, Company table
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00810198920178TeKBraceTheraMicro, LLCMBI2026-08-14
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00810146164449RedifixTRAX SURGICAL INC.MBI2026-07-20
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00810146164692RedifixTRAX SURGICAL INC.MBI2026-07-20
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