Healicoil

FDA UDI

Class II (US FDA UDI)

by Smith & Nephew, Inc.

Identity

Trade Name: HEALICOIL FDA UDI
Generic Name: Tendon/ligament bone anchor, non-bioabsorbable FDA UDI
Device Name: HEALICOIL PK 5.5 MM SUTURE ANCHOR WITH ONE ULTRATAPE SUTURE BLUE AND ONE ULTRABRAID SUTURE No.2 FDA UDI
Model / Reference: 72203983 FDA UDI
Description: HEALICOIL PK 5.5 MM SUTURE ANCHOR WITH ONE ULTRATAPE SUTURE BLUE AND ONE ULTRABRAID SUTURE No.2 FDA UDI

Identifiers

Catalog Number: 72203983 FDA UDI
Primary DI / UDI-DI: 00885554032109 FDA UDI
510(k) Number: K113294 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

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

MRI Safety

MR Safe FDA UDI

Category: Tendon/ligament bone anchor, non-bioabsorbable

Healicoil by Smith & Nephew, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Tendon/ligament bone anchor, non-bioabsorbable.

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Ecobone — Bonegraft Biomaterials Co. · Class III
fX — Bonegraft Biomaterials Co. · Class III
GII PANACRYL — DePuy Mitek, Inc. · Class II
Power Button Adjustable Loop — RIVERPOINT MEDICAL LLC · Class II
SignaLoc Screw — SIGNATURE ORTHOPAEDICS PTY LTD · Class II
JuggerKnot Soft Anchors — Biomet Orthopedics, Inc. · Class II

Cleared under the same submission

K113294 also covers:

HEALICOIL — Smith & Nephew, Inc.
HEALICOIL — Smith & Nephew, Inc.
HEALICOIL — Smith & Nephew, Inc.
HEALICOIL — Smith & Nephew, Inc.
HEALICOIL — Smith & Nephew, Inc.
HEALICOIL / ULTRABRAID — Smith & Nephew, Inc.

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: Smith & Nephew, Inc.

Sources (1)

FDA UDI 9f87ef94-ee13-4283-ae0f-50b3dbb1b1b7 36 fields · synced Jun 8, 2026