Hintermann Series H2 321836

by Dt Medtech, LLC

Active United States. Also listed in GUDID (US), not in commercial distribution.

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

in data synced 23 Oct 2026

Documents

FDA submission, from GUDID

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	NumberB095321836 UDI-DI	Date13 Jan 2020Listed	StatusListed GUDID: not in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK171004	Date7 Nov 2017Decided	StatusActive

Official records

FDA 510(k) database 510(k) number K171004

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Hintermann Series H2
Generic name: Coated ankle tibia prosthesis
Model / Ref / Catalog: 321836

Primary DI / UDI-DI: B095321836
FDA product code: HSN
GMDN term: Coated ankle tibia prosthesis

Device class: Class II
Regulation number: 888.3110
GUDID distribution status: Not in Commercial Distribution

Other devices from Dt Medtech, LLC

See all devices from Dt Medtech, LLC →

Properties

Supplied sterile
Single use
Implantable
Prescription use
Lot / batch number
Expiration date

Other properties (9)

Sterilise before use: No
Contains latex: No
Over-the-counter: No
Convenience kit: No
Combination product: No
HCT/P: No
Premarket exempt: No
Serial number: No
Manufacturing date: No