HWAClass I

Impactor

21 CFR 888.4540 / Orthopedic

HWA is the FDA product code for Impactor, a class I device type, regulated under 21 CFR 888.4540. As of 2026-09-10, FDA records hold 4 510(k) clearances under this code, the most recent dated 1994-01-25, and 27 recalls.

Classification record

Product code: HWA
Device name: Impactor
Regulation: 21 CFR 888.4540
Device class: Class I
Review panel: Orthopedic
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 4
Ingested recalls: 27

Clearances, product code HWA

By decision year

4 clearances under product code HWA with a decision year between 1977 and 1994, 1977 the highest year at 1.

Show the numbers

510(k) clearances under FDA product code HWA by decision year
Year	Clearances
1977	1
1984	1
1986	1
1994	1

Applicants with the most clearances

Product code HWA

Applicants holding the most 510(k) clearances under product code HWA
Applicant	Clearances
Cedar Surgical, Inc.	1
Depuy, Inc.	1
Mira, Inc.	1
Plastafil, Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 280 companies shown, in name order