Modification to Pass Spinal System
FDA 510(k) K020236 · Encore Orthopedics, Inc.
510(k) numberK020236
Submission
- Device name
- Modification to Pass Spinal System
- Applicant
- Encore Orthopedics, Inc.
Austin, TX, US - Received
- January 23, 2002
- Decision date
- February 14, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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 |
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| K032905 | 3DKNEE Porous Coated Femoral ComponentMBH · Traditional | 07/06/2004SE |
| K020114 | 3D KneeJWH · Traditional | 07/12/2002SE |
| K020741 | Unicondylar KneeHRY · Traditional | 06/04/2002SE |
| K020170 | Keystone Hip System Calcar Replacement Body and Build UpLPH · Special | 02/11/2002SE |
| K013490 | Cemented Calcar Hip SystemLPH · Traditional | 01/17/2002SE |
| K013442 | Pass Spinal SystemKWP · Traditional | 01/15/2002SE |
| K003324 | Plasma Sprayed ShoulderKWS · Traditional | 12/06/2001SE |
| K013431 | Pass Spinal SystemMNI · Special | 11/15/2001SE |
| K013191 | Pass Spinal SystemMNI · Special | 10/24/2001SE |
| K011856 | Radiographic MarkersNEU · Traditional | 08/22/2001SE |
Questions and answers
When was Modification to Pass Spinal System cleared by the FDA?
Modification to Pass Spinal System (K020236) received a 510(k) decision of Substantially Equivalent on February 14, 2002, 22 days after the submission was received.
What is the product code of K020236?
The FDA product code is KWP – Appliance, Fixation, Spinal Interlaminal, a Class II (moderate risk) device regulated under 21 CFR 888.3050.