Acromed Ads Bone Nail Driver

FDA 510(k) K875054 · Buckman Co., Inc.

Substantially Equivalent

510(k) numberK875054

Submission

Device name
Acromed Ads Bone Nail Driver
Applicant
Buckman Co., Inc.
Martinez, CA, US
Received
December 9, 1987
Decision date
January 28, 1988
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
HWR – Driver, Prosthesis
Device class
Class I (low risk)
Regulation
21 CFR 888.4540
Specialty
Orthopedic

Other 510(k)s with product code HWR

510(k)DeviceApplicantDecision
K915776Knee Prosthesis DriverHWR · Traditional Kim-Med, Inc.06/11/1992SE
K870848Schultz Metacarpal Component DriverHWR · Traditional Warsaw Orthopedic, Inc.03/13/1987SE
K870847Schultz Phalangeal Component DriverHWR · Traditional Warsaw Orthopedic, Inc.03/13/1987SE

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Questions and answers

When was Acromed Ads Bone Nail Driver cleared by the FDA?

Acromed Ads Bone Nail Driver (K875054) received a 510(k) decision of Substantially Equivalent on January 28, 1988, 50 days after the submission was received.

What is the product code of K875054?

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