TSRH Anterior Spinal Screws, Staples and End Plate
FDA 510(k) K883784 · Warsaw Orthopedic, Inc.
510(k) numberK883784
Submission
- Device name
- TSRH Anterior Spinal Screws, Staples and End Plate
- Applicant
- Warsaw Orthopedic, Inc.
Warsaw, IN, US - Received
- September 6, 1988
- Decision date
- April 6, 1989
- Decision
- Substantially Equivalent for Some Indications (SN)
- Type
- Traditional 510(k)
Device classification
- Product code
- LYQ – Accessories, Fixation, Spinal Intervertebral Body
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 888.4540
- Specialty
- Orthopedic
Other 510(k)s with product code LYQ
More from Terray Manufacturing, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K892877 | Cradle, Hospital Bed ClothingFNJ · Traditional | 06/15/1989SE |
| 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 |
| K870848 | Schultz Metacarpal Component DriverHWR · Traditional | 03/13/1987SE |
Questions and answers
When was TSRH Anterior Spinal Screws, Staples and End Plate cleared by the FDA?
TSRH Anterior Spinal Screws, Staples and End Plate (K883784) received a 510(k) decision of Substantially Equivalent for Some Indications on April 6, 1989, 212 days after the submission was received.
What is the product code of K883784?
The FDA product code is LYQ – Accessories, Fixation, Spinal Intervertebral Body, a Class I (low risk) device regulated under 21 CFR 888.4540.