Acromed Wallie-Heinig Osteotomes

FDA 510(k) K870780 · Buckman Co., Inc.

Substantially Equivalent

510(k) numberK870780

Submission

Device name
Acromed Wallie-Heinig Osteotomes
Applicant
Buckman Co., Inc.
Martinez, CA, US
Received
February 26, 1987
Decision date
March 9, 1987
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
HWM – Osteotome
Device class
Class I (low risk)
Regulation
21 CFR 878.4800
Specialty
General, Plastic Surgery

Other 510(k)s with product code HWM

510(k)DeviceApplicantDecision
K874503Micro-Aire Osteotome System or Bone HarvesterHWM · Traditional Micro-Aire Surgical Instruments, Inc.12/02/1987SE
K771744Osteotomes for Cutting BonhHWM · Traditional Depuy, Inc.09/28/1977SE

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Questions and answers

When was Acromed Wallie-Heinig Osteotomes cleared by the FDA?

Acromed Wallie-Heinig Osteotomes (K870780) received a 510(k) decision of Substantially Equivalent on March 9, 1987, 11 days after the submission was received.

What is the product code of K870780?

The FDA product code is HWM – Osteotome, a Class I (low risk) device regulated under 21 CFR 878.4800.