Osteotomes for Cutting Bonh

FDA 510(k) K771744 · Depuy, Inc.

Substantially Equivalent

510(k) numberK771744

Submission

Device name
Osteotomes for Cutting Bonh
Applicant
Depuy, Inc.
Walker, MI, US
Received
September 15, 1977
Decision date
September 28, 1977
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
K870780Acromed Wallie-Heinig OsteotomesHWM · Traditional Buckman Co., Inc.03/09/1987SE

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Questions and answers

When was Osteotomes for Cutting Bonh cleared by the FDA?

Osteotomes for Cutting Bonh (K771744) received a 510(k) decision of Substantially Equivalent on September 28, 1977, 13 days after the submission was received.

What is the product code of K771744?

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