TSRH H/M Hook, Eyebolt/Lock Nut Assem., Spinal Rod
FDA 510(k) K880215 · Warsaw Orthopedic, Inc.
510(k) numberK880215
Submission
- Device name
- TSRH H/M Hook, Eyebolt/Lock Nut Assem., Spinal Rod
- Applicant
- Warsaw Orthopedic, Inc.
Warsaw, IN, US - Received
- January 19, 1988
- Decision date
- February 18, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KWP – Appliance, Fixation, Spinal Interlaminal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3050
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code KWP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K143278 | LnK Posterior Cervical Fixation SystemKWP · Traditional | L&K BIOMED Co., Ltd. | 07/29/2015SE |
| K150753 | OASYS SystemKWP · Traditional | Stryker Corporation | 06/09/2015SE |
| K150851 | Sure Lok Mini Posterior Cervical/Upper Thoracic SystemKWP · Special | Precision Spine, Inc. | 06/04/2015SE |
| K142867 | Reliance Posterior Cervical-Thoracic SystemKWP · Special | Reliance Medical Systems, LLC | 04/29/2015SE |
| K150254 | Streamline OCT Occipito-Cervico-Thoracic SystemKWP · Traditional | Pioneer Surgical Technology, Inc. (Dba Rti… | 04/28/2015SE |
| K142253 | SOLSTICE OCT SystemKWP · Traditional | Life Spine, Inc. | 04/23/2015SE |
| K150229 | SOLSTICE OCT SystemKWP · Traditional | Life Spine, Inc. | 04/07/2015SE |
| K143249 | SOLSTICE OCT SystemKWP · Traditional | Life Spine, Inc. | 04/07/2015SE |
| K142741 | OASYS SystemKWP · Traditional | Stryker Corporation | 01/15/2015SE |
| K142558 | Caspian OCT/MESA Mini/DENALI Mini Spinal SystemKWP · Special | K2m | 12/22/2014SE |
More from K2m
| 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 |
| 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 H/M Hook, Eyebolt/Lock Nut Assem., Spinal Rod cleared by the FDA?
TSRH H/M Hook, Eyebolt/Lock Nut Assem., Spinal Rod (K880215) received a 510(k) decision of Substantially Equivalent on February 18, 1988, 30 days after the submission was received.
What is the product code of K880215?
The FDA product code is KWP – Appliance, Fixation, Spinal Interlaminal, a Class II (moderate risk) device regulated under 21 CFR 888.3050.