Quantum M05 02001

Active United States. Also listed in GUDID (US).

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	Number03701337618063 UDI-DI	Date13 Dec 2024Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK191380	Date29 Jan 2020Decided	StatusActive

Official records

AccessGUDID record UDI-DI 03701337618063
FDA 510(k) database 510(k) number K191380

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Withdrawn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: Quantum
Generic name: Orthopaedic instrument surgical connector
Model / Ref / Catalog: M05 02001

Primary DI / UDI-DI: 03701337618063
510(k) Number: K191380
FDA product code: FZX
GMDN term: Orthopaedic instrument surgical connector

Device class: Class I
Regulation number: 878.4800
GUDID distribution status: In Commercial Distribution

Sterilisation method: Moist Heat or Steam Sterilization

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Properties

Sterilise before use
Prescription use
Lot / batch number
Manufacturing date

Other properties (11)

Supplied sterile: No
Single use: No
Implantable: No
Contains latex: No
Over-the-counter: No
Convenience kit: No
Combination product: No
HCT/P: No
Premarket exempt: No
Serial number: No
Expiration date: No