Cement Chisels

FDA 510(k) K770205 · Depuy, Inc.

Substantially Equivalent

510(k) numberK770205

Submission

Device name
Cement Chisels
Applicant
Depuy, Inc.
Mchenry, IL, US
Received
January 31, 1977
Decision date
February 8, 1977
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
K841627MalletHWA · Traditional Plastafil, Inc.08/27/1984SE

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K032151Depuy Sigma Tibial Inserts and Co-Cr Tibial TraysJWH · Special 09/26/2003SE
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Questions and answers

When was Cement Chisels cleared by the FDA?

Cement Chisels (K770205) received a 510(k) decision of Substantially Equivalent on February 8, 1977, 8 days after the submission was received.

What is the product code of K770205?

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