Fixone All Suture Anchor

FDA UDI

Class II (US FDA UDI)

by Aju Pharm. Co., Ltd.

Identity

Trade Name: Fixone All Suture Anchor FDA UDI
Generic Name: Tendon/ligament bone anchor, non-bioabsorbable FDA UDI
Device Name: 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. FDA UDI
Model / Reference: FAS-1652803jw FDA UDI
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. FDA UDI

Identifiers

Primary DI / UDI-DI: 08800039100465 FDA UDI
510(k) Number: K222423 FDA UDI
FDA Product Code: MBI FDA UDI
GMDN Term: Tendon/ligament bone anchor, non-bioabsorbable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3040 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Tendon/ligament bone anchor, non-bioabsorbable

Fixone All Suture Anchor by Aju Pharm. Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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SignaLoc Screw — SIGNATURE ORTHOPAEDICS PTY LTD · Class II
JuggerKnot Soft Anchors — Biomet Orthopedics, Inc. · Class II

Cleared under the same submission

K222423 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Aju Pharm. Co., Ltd.

Sources (1)

FDA UDI c6e4edad-fbfc-47da-9a69-f0bc89e3a568 34 fields · synced Jun 1, 2026