Poly Suture Button

FDA UDI

Class I (US FDA UDI)

by Biomet Sports Medicine

Identity

Trade Name: POLY SUTURE BUTTON FDA UDI
Generic Name: Ligament bone anchor FDA UDI
Model / Reference: 904215 FDA UDI

Identifiers

Catalog Number: 904215 FDA UDI
Primary DI / UDI-DI: 00880304405363 FDA UDI
510(k) Number: K813581 FDA UDI
FDA Product Code: KGS FDA UDI
GMDN Term: Ligament bone anchor FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4930 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

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

FDA UDI

Category: Ligament bone anchor

Poly Suture Button by Biomet Sports Medicine — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ligament bone anchor.

EZLOC™ — Biomet Orthopedics, Inc. · Class II
JUGGERKNOT — Biomet Orthopedics, Inc. · Class II
M-ARS ACL: Anatomic Ribbon Surgery System — Medacta International · Class II
Corifix Ligament Anchor Screw — CORIN LTD · Class II
Corifix Ligament Anchor Screw — CORIN LTD · Class II
XTENDOBUTTON — Smith & Nephew, Inc. · Class I
Spirit — RESPONSIVE ORTHOPEDICS LLC · Class II
Lateral Suture Anchor, PEEK 6.5mm x 20mm — BIOPRO, INC. · Class II

Cleared under the same submission

K813581 also covers:

POLY SUTURE BUTTON — Biomet Sports Medicine

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 I	Pending data

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

Manufacturer

Manufacturer: Biomet Sports Medicine

Sources (1)

FDA UDI eb81c5d5-bd64-40ad-990d-2981b5e16eb0 36 fields · synced May 30, 2026