Hip Plate Removal Instrument
FDA 510(k) K780300 · Richard'S Medical Equip., Inc.
510(k) numberK780300
Submission
- Device name
- Hip Plate Removal Instrument
- Applicant
- Richard'S Medical Equip., Inc.
Mchenry, IL, US - Received
- February 22, 1978
- Decision date
- February 28, 1978
- 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 |
| K870083 | Ferray ExtractorHWB · Traditional | Terray Manufacturing, Inc. | 02/26/1987SE |
| K801327 | The Extractor I TMHWB · Traditional | The Anspach Effort, Inc. | 06/09/1980SE |
More from The Anspach Effort, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K830793 | Patient Guided Elbow & Shoulder ExercBXB · Traditional | 06/16/1983SE |
| K823837 | RMC Total Knee SystemMBV · Traditional | 03/29/1983SE |
| K823726 | Spectron Conversion Endoprosthesis CupKWY · Traditional | 03/09/1983SE |
| K823724 | Spectron Neck Replacement ProsthesisJDI · Traditional | 03/09/1983SE |
| K823723 | Spectron Proximal Femoral ProsthesisJDI · Traditional | 03/09/1983SE |
| K823727 | Spectron Primary Stem Femoral ProsthesJDI · Traditional | 03/08/1983SE |
| K823722 | Spectron Long, Straight Femoral ProsthesJDI · Traditional | 03/08/1983SE |
| K830153 | Richards Intra-Articular Shaver BladesGEY · Traditional | 02/28/1983SE |
| K830154 | Colles Fracture FrameJEC · Traditional | 02/02/1983SE |
| K823729 | Spectron Metal Back Acetabular ComponentJDI · Traditional | 01/21/1983SE |
Questions and answers
When was Hip Plate Removal Instrument cleared by the FDA?
Hip Plate Removal Instrument (K780300) received a 510(k) decision of Substantially Equivalent on February 28, 1978, 6 days after the submission was received.
What is the product code of K780300?
The FDA product code is HWB – Extractor, a Class I (low risk) device regulated under 21 CFR 888.4540.