InCore Subtalar ICSUB55088

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	Number00817701029038 UDI-DI	Date31 Jan 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Withdrawn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 bone screw (non-sliding)
Model / Reference: ICSUB55088

Primary DI / UDI-DI: 00817701029038
FDA Product Code: HWC
GMDN Term: Orthopaedic bone screw (non-sliding)

Device Class: Class II
Regulation Number: 888.3040
GUDID distribution status: Not in Commercial Distribution

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Properties

Sterile
Single Use
Implantable
Contains Latex
Lot / Batch Number
Expiration Date
Manufacturing Date

Other properties (7)

Prescription Use: No
Over-the-Counter: No
Convenience Kit: No
Combination Product: No
HCT/P: No
Premarket Exempt: No
Serial Number: No