Schultz Metacarpal Component Driver
FDA 510(k) K870848 · Warsaw Orthopedic, Inc.
510(k) numberK870848
Submission
- Device name
- Schultz Metacarpal Component Driver
- 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
- HWR – Driver, Prosthesis
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 888.4540
- Specialty
- Orthopedic
Other 510(k)s with product code HWR
More from Warsaw Orthopedic, 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 Metacarpal Component Driver cleared by the FDA?
Schultz Metacarpal Component Driver (K870848) 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 K870848?
The FDA product code is HWR – Driver, Prosthesis, a Class I (low risk) device regulated under 21 CFR 888.4540.