Who is the manufacturer of SYNTHES STERILE DRILL BITS?

Synthes (Usa) filed the 510(k) submission for SYNTHES STERILE DRILL BITS (K962913).

What is the FDA product code for SYNTHES STERILE DRILL BITS?

HWE. It is classified under 21 CFR 878.4820 as a Class 1 device in the General, Plastic Surgery panel.

What is the regulatory pathway for SYNTHES STERILE DRILL BITS?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like SYNTHES STERILE DRILL BITS?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

SYNTHES STERILE DRILL BITS

K962913 · Synthes (Usa) · HWE · Nov 14, 1996 · General, Plastic Surgery

Device Facts

Record ID	K962913
Device Name	SYNTHES STERILE DRILL BITS
Applicant	Synthes (Usa)
Product Code	HWE · General, Plastic Surgery
Decision Date	Nov 14, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4820
Device Class	Class 1

Intended Use

Synthes Sterile Drill Bits are intended to bore a hole into bone for insertion of a screw, wire, cable, plate, pin, bolt, etc.

Device Story

Sterile drill bits used by surgeons in clinical/OR settings to create pilot holes in bone; facilitates subsequent insertion of orthopedic fixation hardware (screws, pins, plates, etc.). Device features fluted design; available in solid or cannulated configurations; includes various coupling mechanisms and size options. Provided sterile to user to ensure surgical readiness.

Clinical Evidence

bench testing only

Technological Characteristics

Fluted drill bits; solid or cannulated; various lengths/diameters; various coupling mechanisms; gamma radiation sterilization.

Indications for Use

Indicated for patients requiring bone drilling for the insertion of orthopedic fixation hardware such as screws, wires, cables, plates, pins, or bolts.

Regulatory Classification

Identification

Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.

Related Devices

K102743 — ORTHO SOLUTIONS - STERILE, DRILLS, TAPS, GUIDE PINS & WIRES · Ortho Solutions Limited · Jan 20, 2011
K213208 — Twist Drills · Biomet Microfixation · Dec 23, 2021
K151661 — Renovo Life Hard Carbon Coated Drill Bit · Renovo Life, LLC · Jan 15, 2016
K960720 — EXACTECH STERILE MODULAR DRILL BIT · Exactech, Inc. · Apr 23, 1996
K070876 — STRYKER TWIST DRILLS · Stryker Craniomaxillofacial · Apr 27, 2007

Submission Summary (Full Text)

{0} SYNTHES K962913 Attachment IV: Summary of Safety and Effectiveness Information | Synthes (USA) | (610) 647 - 9700 | NOV 14 1996 | | --- | --- | --- | | 1690 Russell Road | Contact: Angela J. Silvestri | | | Paoli, PA 19301 | July 1996 | | Synthes commercially available Drill Bits are being made available as sterile. Synthes Sterile Drill Bits are intended to bore a hole into bone for insertion of a screw, wire, cable, plate, pin, bolt, etc. Synthes Sterile Drill Bits are available in various sizes and lengths, have a fluted design, and are either solid or cannulated, and may be calibrated. The Synthes Sterile Drill Bits have various coupling mechanisms. Synthes Drill Bits will be provided to the user sterile. Gamma radiation will be used to sterilize the device.