Andrews Remote Chuck Drill
FDA 510(k) K831043 · Orthopedic Systems, Inc.
510(k) numberK831043
Submission
- Device name
- Andrews Remote Chuck Drill
- Applicant
- Orthopedic Systems, Inc.
Mchenry, IL, US - Received
- March 31, 1983
- Decision date
- April 28, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HXY – Brace, Drill
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 888.4540
- Specialty
- Orthopedic
Other 510(k)s with product code HXY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K923776 | Benderev Drill GuideHXY · Traditional | Neimark Labs, Inc. | 11/06/1992SE |
| K892904 | Mitek Drill GuideHXY · Traditional | Mitek Surgical Products, Inc. | 09/28/1989SE |
| K880264 | Bone Suture Fixation DeviceHXY · Traditional | Orthopedic Systems, Inc. | 03/23/1988SN |
| K880381 | Telos Distal Targeting DeviceHXY · Traditional | Austin Assoc. | 03/15/1988SE |
| K880046 | Hasting Finger Fixator InstrumentsHXY · Traditional | Buckman Co., Inc. | 02/16/1988SE |
| K770204 | Cement Extractor DrillHXY · Traditional | Depuy, Inc. | 02/08/1977SE |
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| K910031 | Park City Shoulder PositionerFWZ · Traditional | 01/24/1991SE |
| K903938 | C Fit CupJDI · Traditional | 01/04/1991SN |
| K892503 | Nuffield Total KneeJWH · Traditional | 05/04/1990SN |
| K896678 | Silicone PlugHRX · Traditional | 01/30/1990SE |
| K894283 | Comprehensive Spine Motion AnalyzerKQX · Traditional | 01/19/1990SE |
| K890498 | Freeman Modular Hip Stem Ridged VersionJDI · Traditional | 10/13/1989SN |
| K890331 | Freeman Total Hip System Ridged StemLWJ · Traditional | 10/13/1989SE |
Questions and answers
When was Andrews Remote Chuck Drill cleared by the FDA?
Andrews Remote Chuck Drill (K831043) received a 510(k) decision of Substantially Equivalent on April 28, 1983, 28 days after the submission was received.
What is the product code of K831043?
The FDA product code is HXY – Brace, Drill, a Class I (low risk) device regulated under 21 CFR 888.4540.