FuzeFix Large CD-FX-3055

by Fusion Orthopedics, LLC

FuzeFix Large CD-FX-3055 is a Class II device made by Fusion Orthopedics, LLC, cleared under FDA 510(k) K170038 on 7 Aug 2017 and listed in FDA GUDID since 22 Apr 2019 (UDI-DI 00819034025732), active as of 23 Oct 2026.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

FDA submission, from GUDID

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00819034025732 UDI-DI	Date22 Apr 2019Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK170038	Date7 Aug 2017Decided	StatusActive

Official records

AccessGUDID record UDI-DI 00819034025732
FDA 510(k) database 510(k) number K170038

Across registries

2 registries list this device

FDA 510(k) K170038 decided 7 Aug 2017 Active
FDA GUDID UDI-DI 00819034025732 listed 22 Apr 2019 Listed

Timeline

2 dated events

7 Aug 2017 Cleared FDA 510(k) K170038
22 Apr 2019 Listed FDA GUDID 00819034025732

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: FuzeFix Large
Generic name: Surgical screwdriver, single-use, non-sterile
Model / Ref / Catalog: CD-FX-3055

Primary DI / UDI-DI: 00819034025732
510(k) Number: K170038
FDA product code: HWC
GMDN term: Surgical screwdriver, single-use, non-sterile

Device class: Class II
Regulation number: 888.3040
GUDID distribution status: In Commercial Distribution

Sterilisation method: Moist Heat or Steam Sterilization

Other devices from Fusion Orthopedics USA, LLC

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Properties

Sterilise before use
Single use
Prescription use
Lot / batch number
Expiration date
Manufacturing date

Other properties (9, all answered No)