Curvtek TSR System

Q: When was Curvtek TSR System cleared by the FDA?

Curvtek TSR System (K972860) received a 510(k) decision of Substantially Equivalent on October 31, 1997, 88 days after the submission was received.

Q: What is the product code of K972860?

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.

FDA 510(k) K972860 · Biolectron, Inc.

Substantially Equivalent

510(k) numberK972860

Submission

Device name: Curvtek TSR System
Applicant: Biolectron, Inc.
Hackensack, NJ, US
Received: August 4, 1997
Decision date: October 31, 1997
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)	Device	Applicant	Decision
K991588	EMS Swiss OrthoclastHSZ · Traditional	(Ems Sa) Electro Medical Systems	07/21/1999SE
K970345	Alignment InstrumentHSZ · Traditional	Richard Wolf Medical Instruments Corp.	04/29/1997SE
K955084	Aspach 65,000 (Modification)HSZ · Traditional	The Anspach Effort, Inc.	01/17/1996SE
K954080	Sodem High Speed SystemHSZ · Traditional	Sodem Diffusion SA	10/16/1995SE
K944590	Ethicon Drill Bit and Drill GuideHSZ · Traditional	ETHICON, Inc.	05/11/1995SE
K934336	SpinalplaneHSZ · Traditional	Synvasive Technology, Inc.	03/10/1995SN
K940276	Filter, DiffuserHSZ · Traditional	Anspach Mfg., Inc.	11/16/1994SE
K942760	Pneumatic Wire TensionerHSZ · Traditional	Smith & Nephew Richards, Inc.	09/06/1994SE
K941681	Arthrex Circular Harvesting SawHSZ · Traditional	Arthrex, Inc.	08/25/1994SE
K935367	Tava Wire-DriverHSZ · Traditional	Tava Surgical Instruments	04/21/1994SE

Questions and answers

When was Curvtek TSR System cleared by the FDA?

Curvtek TSR System (K972860) received a 510(k) decision of Substantially Equivalent on October 31, 1997, 88 days after the submission was received.

What is the product code of K972860?

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.