Mallet

FDA 510(k) K841627 · Plastafil, Inc.

Substantially Equivalent

510(k) numberK841627

Submission

Device name
Mallet
Applicant
Plastafil, Inc.
Mchenry, IL, US
Received
April 19, 1984
Decision date
August 27, 1984
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
HWA – Impactor
Device class
Class I (low risk)
Regulation
21 CFR 888.4540
Specialty
Orthopedic

Other 510(k)s with product code HWA

510(k)DeviceApplicantDecision
K933527Modification of Anterior Segment ElectrodesHWA · Traditional Mira, Inc.01/25/1994SE
K864422Raylor(Tm) MalletHWA · Traditional Cedar Surgical, Inc.11/24/1986SE
K770205Cement ChiselsHWA · Traditional Depuy, Inc.02/08/1977SE

More from Depuy, Inc.

510(k)DeviceDecision
K841621Back Radius CutterHTX · Traditional 09/20/1984SE
K841620Front Radius CutterHTX · Traditional 09/20/1984SE
K841629Drill BitHTW · Traditional 08/27/1984SE
K841626PunchHXG · Traditional 08/27/1984SE
K841625HookGAD · Traditional 08/27/1984SE
K841624ProbeHRX · Traditional 08/27/1984SE
K841618Threading TubeFZX · Traditional 08/27/1984SE
K841617Strover HookHCF · Traditional 08/27/1984SE
K841628WireHXN · Traditional 07/23/1984SE
K841623Slotted Soft-Tissue InstrumentHWQ · Traditional 07/11/1984SE

Questions and answers

When was Mallet cleared by the FDA?

Mallet (K841627) received a 510(k) decision of Substantially Equivalent on August 27, 1984, 130 days after the submission was received.

What is the product code of K841627?

The FDA product code is HWA – Impactor, a Class I (low risk) device regulated under 21 CFR 888.4540.