Schultz Phalangeal Comp Trial/Metacarpal Comp Tria
FDA 510(k) K870843 · Warsaw Orthopedic, Inc.
510(k) numberK870843
Submission
- Device name
- Schultz Phalangeal Comp Trial/Metacarpal Comp Tria
- Applicant
- Warsaw Orthopedic, Inc.
Warsaw, IN, US - Received
- March 3, 1987
- Decision date
- May 27, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HWT – Template
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 888.4800
- Specialty
- Orthopedic
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| K960685 | Orthodoc Preoperative Planner Model 500HWT · Traditional | Integrated Surgical Systems, Inc. | 01/17/1997SE |
| K894228 | Kronner Spherical CuttersHWT · Traditional | Kronner Medical | 07/23/1990SE |
| K871323 | Arthroscopic Meniscal Suture SystemHWT · Traditional | Orthopedic Systems, Inc. | 05/01/1987SE |
| K830360 | 3M Osteotomy GuideHWT · Traditional | 3M Company | 03/01/1983SE |
| K811205 | Molded Polysulfone Trial ProsthesisHWT · Traditional | Shannon Group | 05/21/1981SE |
| K781091 | Knee Instrumentation, CondylarHWT · Traditional | Biomet, Inc. | 07/17/1978SE |
| K771710 | Worrell Patella TemplateHWT · Traditional | Depuy, Inc. | 10/06/1977SE |
| K771709 | Worrell Trial PatellaHWT · Traditional | Depuy, Inc. | 10/06/1977SE |
More from Depuy, 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 |
| K870842 | Schultz Phalangeal Comp Rasp/Metacarpal Comp RaspHTP · Traditional | 05/27/1987SE |
| K870830 | Warsaw Orthopedic TSR Cross Link SystemKWP · Traditional | 05/04/1987SE |
| K870848 | Schultz Metacarpal Component DriverHWR · Traditional | 03/13/1987SE |
Questions and answers
When was Schultz Phalangeal Comp Trial/Metacarpal Comp Tria cleared by the FDA?
Schultz Phalangeal Comp Trial/Metacarpal Comp Tria (K870843) received a 510(k) decision of Substantially Equivalent on May 27, 1987, 85 days after the submission was received.
What is the product code of K870843?
The FDA product code is HWT – Template, a Class I (low risk) device regulated under 21 CFR 888.4800.