EMS Swiss Orthoclast

FDA 510(k) K991588 · (Ems Sa) Electro Medical Systems

Substantially Equivalent

510(k) numberK991588

Submission

Device name
EMS Swiss Orthoclast
Applicant
(Ems Sa) Electro Medical Systems
North Attleboro, MA, US
Received
May 7, 1999
Decision date
July 21, 1999
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
HSZ – Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment
Device class
Class I (low risk)
Regulation
21 CFR 878.4820
Specialty
General, Plastic Surgery

Other 510(k)s with product code HSZ

510(k)DeviceApplicantDecision
K972860Curvtek TSR SystemHSZ · Traditional Biolectron, Inc.10/31/1997SE
K970345Alignment InstrumentHSZ · Traditional Richard Wolf Medical Instruments Corp.04/29/1997SE
K955084Aspach 65,000 (Modification)HSZ · Traditional The Anspach Effort, Inc.01/17/1996SE
K954080Sodem High Speed SystemHSZ · Traditional Sodem Diffusion SA10/16/1995SE
K944590Ethicon Drill Bit and Drill GuideHSZ · Traditional ETHICON, Inc.05/11/1995SE
K934336SpinalplaneHSZ · Traditional Synvasive Technology, Inc.03/10/1995SN
K940276Filter, DiffuserHSZ · Traditional Anspach Mfg., Inc.11/16/1994SE
K942760Pneumatic Wire TensionerHSZ · Traditional Smith & Nephew Richards, Inc.09/06/1994SE
K941681Arthrex Circular Harvesting SawHSZ · Traditional Arthrex, Inc.08/25/1994SE
K935367Tava Wire-DriverHSZ · Traditional Tava Surgical Instruments04/21/1994SE

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510(k)DeviceDecision
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K032099Swiss Master LightEBZ · Traditional 10/27/2003SE
K992504EMS KermitELC · Traditional 01/27/2000SE
K991874EMS Surface Mount ScalerELC · Traditional 07/30/1999SE

Questions and answers

When was EMS Swiss Orthoclast cleared by the FDA?

EMS Swiss Orthoclast (K991588) received a 510(k) decision of Substantially Equivalent on July 21, 1999, 75 days after the submission was received.

What is the product code of K991588?

The FDA product code is HSZ – Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment, a Class I (low risk) device regulated under 21 CFR 878.4820.