Schultz Prosthesis Component Inserter Extractor
FDA 510(k) K870844 · Warsaw Orthopedic, Inc.
510(k) numberK870844
Submission
- Device name
- Schultz Prosthesis Component Inserter Extractor
- Applicant
- Warsaw Orthopedic, Inc.
Warsaw, IN, US - Received
- March 3, 1987
- Decision date
- March 13, 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 |
| K870083 | Ferray ExtractorHWB · Traditional | Terray Manufacturing, Inc. | 02/26/1987SE |
| 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 |
|---|---|---|
| K892877 | Cradle, Hospital Bed ClothingFNJ · Traditional | 06/15/1989SE |
| K883784 | TSRH Anterior Spinal Screws, Staples and End PlateLYQ · Traditional | 04/06/1989SN |
| K883783 | TSRH Sacral Spinal ScrewKWP · Traditional | 04/06/1989SN |
| K880212 | TSRH H/M Hook Holder W/Rod MoverKWP · Traditional | 03/04/1988SE |
| K880211 | TSRH H/M Hook HolderKWP · Traditional | 03/04/1988SE |
| K880215 | TSRH H/M Hook, Eyebolt/Lock Nut Assem., Spinal RodKWP · Traditional | 02/18/1988SE |
| K880214 | TSRH H/M Torque Limiting WrenchKWP · Traditional | 02/18/1988SE |
| K870843 | Schultz Phalangeal Comp Trial/Metacarpal Comp TriaHWT · Traditional | 05/27/1987SE |
| K870842 | Schultz Phalangeal Comp Rasp/Metacarpal Comp RaspHTP · Traditional | 05/27/1987SE |
| K870830 | Warsaw Orthopedic TSR Cross Link SystemKWP · Traditional | 05/04/1987SE |
Questions and answers
When was Schultz Prosthesis Component Inserter Extractor cleared by the FDA?
Schultz Prosthesis Component Inserter Extractor (K870844) received a 510(k) decision of Substantially Equivalent on March 13, 1987, 10 days after the submission was received.
What is the product code of K870844?
The FDA product code is HWB – Extractor, a Class I (low risk) device regulated under 21 CFR 888.4540.