Mallet, Bone Surgery, Stainless Steel, 2LB.

FDA 510(k) K871195 · Military Engineering, Inc.

Substantially Equivalent

510(k) numberK871195

Submission

Device name
Mallet, Bone Surgery, Stainless Steel, 2LB.
Applicant
Military Engineering, Inc.
Plymouth, IN, US
Received
March 24, 1987
Decision date
April 6, 1987
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

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

Other 510(k)s with product code HXL

510(k)DeviceApplicantDecision
K882349Mallet, SurgicalHXL · Traditional Treace Medical, Inc.06/23/1988SE
K872209Arthroplasty MalletHXL · Traditional New England Surgical Instrument Corp.06/23/1987SE

More from New England Surgical Instrument Corp.

510(k)DeviceDecision
K874335Explorer-Dental ProberEKJ · Traditional 12/29/1987SE
K873715Bone Pin Cutter 18HXZ · Traditional 10/28/1987SE
K872842Pin, Hip, KnowlesHTY · Traditional 08/07/1987SE
K872091Currettes, Alveolar (Molt and Miller)EMS · Traditional 07/31/1987SE
K871834Drill, Hand, Bone, SmedbergDZJ · Traditional 07/31/1987SE
K872738Cortical Bone ScrewsHWC · Traditional 07/30/1987SE
K872609Curette Set, Antrum, CoakleyKAP · Traditional 07/15/1987SE
K871818Spatula, Dental, CementEJB · Traditional 07/02/1987SE
K872092Osteotome Set, Hoke, Straight, Set of 5KDG · Traditional 06/23/1987SE
K870590Curette, Periodontal, Columbia UniversityEMS · Traditional 04/16/1987SE

Questions and answers

When was Mallet, Bone Surgery, Stainless Steel, 2LB. cleared by the FDA?

Mallet, Bone Surgery, Stainless Steel, 2LB. (K871195) received a 510(k) decision of Substantially Equivalent on April 6, 1987, 13 days after the submission was received.

What is the product code of K871195?

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