Ferray Extractor
FDA 510(k) K870083 · Terray Manufacturing, Inc.
510(k) numberK870083
Submission
- Device name
- Ferray Extractor
- Applicant
- Terray Manufacturing, Inc.
Ontario K7s 1l8, CA - Received
- January 8, 1987
- Decision date
- February 26, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HWB – Extractor
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 888.4540
- Specialty
- Orthopedic
Other 510(k)s with product code HWB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K873710 | Magnetic Retriever, 1.7MM W/Luer Fitting TM-1350HWB · Traditional | Arthropedics, Inc. | 11/02/1987SE |
| K870844 | Schultz Prosthesis Component Inserter ExtractorHWB · Traditional | Warsaw Orthopedic, Inc. | 03/13/1987SE |
| K801327 | The Extractor I TMHWB · Traditional | The Anspach Effort, Inc. | 06/09/1980SE |
| K780300 | Hip Plate Removal InstrumentHWB · Traditional | Richard'S Medical Equip., Inc. | 02/28/1978SE |
More from Richard'S Medical Equip., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K910874 | Thoracic Anterior Spinal Fixation PlateKWQ · Traditional | 02/03/1992SE |
| K882934 | Casf Cancellous Bone Screw, BT650HWC · Traditional | 10/13/1988SE |
| K882871 | Casf Drill Guide DG 170LYQ · Traditional | 09/23/1988SN |
| K883193 | Casf Sterilization TrayFSM · Traditional | 08/10/1988SE |
| K883125 | Casf Sterilization TrayFSM · Traditional | 08/10/1988SE |
| K870085 | Anterior Spinal Fixation PlateKWP · Traditional | 06/30/1987SE |
| K870082 | Bone PlateHRS · Traditional | 05/06/1987SE |
| K870084 | RD 140 Surgical BenderHXW · Traditional | 01/28/1987SE |
Questions and answers
When was Ferray Extractor cleared by the FDA?
Ferray Extractor (K870083) received a 510(k) decision of Substantially Equivalent on February 26, 1987, 49 days after the submission was received.
What is the product code of K870083?
The FDA product code is HWB – Extractor, a Class I (low risk) device regulated under 21 CFR 888.4540.