SURESTITCH™ UHMWPE Suture PEEK Button Meniscus repair Implant-Right

FDA UDI

Class II (US FDA UDI)

by Healthium Medtech Limited

Identity

Trade Name: SURESTITCH™ UHMWPE Suture PEEK Button Meniscus repair Implant-Right FDA UDI
Generic Name: Meniscus suture anchor FDA UDI
Model / Reference: S29-1802-TQ FDA UDI

Identifiers

Primary DI / UDI-DI: 08903837093844 FDA UDI
510(k) Number: K230891 FDA UDI
FDA Product Code: MBI FDA UDI
GMDN Term: Meniscus suture anchor 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

Yes

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

Yes

FDA UDI

MRI Safety

MR Safe FDA UDI

Category: Meniscus suture anchor

SURESTITCH™ UHMWPE Suture PEEK Button Meniscus repair Implant-Right by Healthium Medtech Limited — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Meniscus suture anchor.

Meniscus Suture - OUT IN — GM DOS REIS INDUSTRIA E COMERCIO LTDA · Class I
MENIX — S.B.M · Class II
MENIX DUO — S.B.M · Class II
SURESTITCH™ UHMWPE Suture PEEK Button Meniscus repair Implant-Down — HEALTHIUM MEDTECH LIMITED · Class II
SURESTITCH™ UHMWPE Suture PEEK Button Meniscus repair Implant-Left — HEALTHIUM MEDTECH LIMITED · Class II
SURESTITCH™ UHMWPE Suture PEEK Button Meniscus repair Implant-UP — HEALTHIUM MEDTECH LIMITED · Class II

Cleared under the same submission

K230891 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Healthium Medtech Limited

Sources (1)

FDA UDI 75f6eca1-3bdd-4e32-a950-f4ea8751f9e9 33 fields · synced May 30, 2026