FastFrame® 47-5300-070-00

by Zimmer, Inc.

FastFrame® 47-5300-070-00 is a Class II device made by Zimmer, Inc., cleared under FDA 510(k) K152755 on 21 Dec 2015 and listed in FDA GUDID since 16 Apr 2021 (UDI-DI 00889024616356), active as of 22 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 22 Oct 2026

Documents

FDA submission, from GUDID

Trust

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00889024616356 UDI-DI	Date16 Apr 2021Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK152755	Date21 Dec 2015Decided	StatusActive

Official records

AccessGUDID record UDI-DI 00889024616356
FDA 510(k) database 510(k) number K152755

Across registries

2 registries list this device

FDA 510(k) K152755 decided 21 Dec 2015 Active
FDA GUDID UDI-DI 00889024616356 listed 16 Apr 2021 Listed

Timeline

2 dated events

21 Dec 2015 Cleared FDA 510(k) K152755
16 Apr 2021 Listed FDA GUDID 00889024616356

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: FastFrame®
Generic name: External orthopaedic fixation system noninvasive component, single-use
Model / Ref / Catalog: 47-5300-070-00

Primary DI / UDI-DI: 00889024616356
510(k) Number: K152755
FDA product code: KTT, JDW
GMDN term: External orthopaedic fixation system noninvasive component, single-use

Device class: Class II
Regulation number: 888.3030, 888.3040
GUDID distribution status: In Commercial Distribution

MRI safety: MR Conditional

Other devices from Zimmer, Inc.

See all devices from Zimmer, Inc. →

Properties

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

Other properties (10, all answered No)