InCore Subtalar ICSUBRSH

by Medartis Inc.

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00817701028727 UDI-DI	Date7 Feb 2023Listed	StatusListed GUDID: not in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: InCore Subtalar
Generic Name: Orthopaedic inorganic implant inserter/extractor, reusable
Model / Reference: ICSUBRSH

Primary DI / UDI-DI: 00817701028727
FDA Product Code: LXH
GMDN Term: Orthopaedic inorganic implant inserter/extractor, reusable

Device Class: Class I
Regulation Number: 888.4540
GUDID distribution status: Not in Commercial Distribution

Sterilization Method: Moist Heat or Steam Sterilization

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Properties

Lot / Batch Number
Manufacturing Date

Other properties (12)

Sterile: No
Single Use: No
Implantable: No
Contains Latex: No
Prescription Use: No
Over-the-Counter: No
Convenience Kit: No
Combination Product: No
HCT/P: No
Premarket Exempt: No
Serial Number: No
Expiration Date: No