Black Diamond Pedicle Screw System
FDA 510(k) K192121 · Osseus Fusion Systems
510(k) numberK192121
Submission
- Device name
- Black Diamond Pedicle Screw System
- Applicant
- Osseus Fusion Systems
Dallas, TX, US - Received
- August 6, 2019
- Decision date
- October 29, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NKB – Thoracolumbosacral Pedicle Screw System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3070
- Specialty
- Orthopedic
- Implant
- Yes
Intended to provide immobilization and stabilization of spinal segments in thoracic, lumbar, and sacral spine as an adjunct to fusion.
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| K253802 | KHEIRON® Spinal Fixation System, including patient specific K-RODNKB · Special | S.M.A.I.O | 07/01/2026SE |
| K253045 | Socko Vimax Spinal Fixation SystemNKB · Traditional | Socko Medical Co., Ltd. | 06/17/2026SE |
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| K260989 | Varion Thoracolumbar Fixation SystemNKB · Traditional | Kyocera Medical Technologies Inc. (KMTI) | 05/15/2026SE |
| K253739 | SCRIPT Rods, CREO Stabilization System, REVERE® Stabilization System, REVERE® 4.5…NKB · Traditional | Globus Medical, Inc. | 05/07/2026SE |
| K261130 | AccelFix Spinal Fixation SystemNKB · Special | L&K BIOMED Co., Ltd. | 05/05/2026SE |
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| K213935 | PISCES-SA Standalone ALIF Interbody SystemOVD · Traditional | 05/06/2022SE |
| K213590 | Blue Topaz Sacroiliac Screw SystemOUR · Traditional | 03/01/2022SE |
| K192495 | Black Diamond Navigation InstrumentsOLO · Traditional | 01/17/2020SE |
| K181347 | Aries® Lumbar InterbodiesMAX · Traditional | 08/15/2018SE |
| K170844 | Gemini-C Hybrid Cervical Interbody SystemODP · Traditional | 07/03/2017SE |
| K160522 | White Pearl Preferred Angle Anterior Cervical PlateKWQ · Traditional | 04/26/2016SE |
| K131810 | Osseus Black Diamond Pedicle Screw SystemMNH · Traditional | 08/08/2013SE |
Questions and answers
When was Black Diamond Pedicle Screw System cleared by the FDA?
Black Diamond Pedicle Screw System (K192121) received a 510(k) decision of Substantially Equivalent on October 29, 2019, 84 days after the submission was received.
What is the product code of K192121?
The FDA product code is NKB – Thoracolumbosacral Pedicle Screw System, a Class II (moderate risk) device regulated under 21 CFR 888.3070.