Femur Wrench
FDA 510(k) K870126 · Orthopedic Systems, Inc.
510(k) numberK870126
Submission
- Device name
- Femur Wrench
- Applicant
- Orthopedic Systems, Inc.
Hayward, CA, US - Received
- January 12, 1987
- Decision date
- February 3, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GEG – Elevator, Surgical, General & Plastic Surgery
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code GEG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K891899 | Elevators, Various TypesGEG · Traditional | Zinnanti Surgical Instruments, Inc. | 04/12/1989SE |
| K891894 | Elevators-Cottle,Mckenty,Goldman,Joseph,ConverseGEG · Traditional | Zinnanti Surgical Instruments, Inc. | 04/12/1989SE |
| K890365 | Septum ElevatorGEG · Traditional | Kinetic Medical Products | 02/03/1989SE |
| K890253 | Surgical ElevatorGEG · Traditional | Kinetic Medical Products | 01/27/1989SE |
| K890230 | Ligature NeedlesGEG · Traditional | Kinetic Medical Products | 01/27/1989SE |
| K872491 | 1.1 Twist Drills and 1.2 Cortical DrillsGEG · Traditional | Micro-Aire Surgical Instruments, Inc. | 07/16/1987SE |
| K870781 | Acromed Wallie-Heinig Disector/ElevatorsGEG · Traditional | Buckman Co., Inc. | 03/09/1987SE |
| K870591 | Elevator, Cobb SpinalGEG · Traditional | Military Engineering, Inc. | 02/26/1987SE |
| K864421 | Raylor(Tm) Periosteal ElevatorsGEG · Traditional | Cedar Surgical, Inc. | 11/26/1986SE |
| K834176 | H.R. Jakobi Surg. Instruments 40/41GEG · Traditional | Imm Enterprises , Ltd. | 01/27/1984SE |
More from Imm Enterprises , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K952495 | Anchors Away Soft Tissue Attachment SystemLXH · Traditional | 01/22/1996SE |
| K920256 | Spine Motion Analyzer with EmgKQX · Traditional | 08/10/1992SE |
| K910736 | Jackson Multipurpose Operating TableJEA · Traditional | 05/21/1991SE |
| 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 Femur Wrench cleared by the FDA?
Femur Wrench (K870126) received a 510(k) decision of Substantially Equivalent on February 3, 1987, 22 days after the submission was received.
What is the product code of K870126?
The FDA product code is GEG – Elevator, Surgical, General & Plastic Surgery, a Class I (low risk) device regulated under 21 CFR 878.4800.