Perla® Posterior Cervico-Thoracic Fixation System
FDA 510(k) K190071 · Spineart
510(k) numberK190071
Submission
- Device name
- Perla® Posterior Cervico-Thoracic Fixation System
- Applicant
- Spineart
Plan Les Ouates, CH - Received
- January 15, 2019
- Decision date
- February 25, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NKG – Posterior Cervical Screw System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3075
- Specialty
- Orthopedic
- Implant
- Yes
Posterior cervical screw systems are intended for use in fusion procedures of the cervical spine and/or craniocervical junction and/or cervicothoracic junction for: 1) spinal fractures and dislocations; 2) deformities; 3) instabilities; 4) failed previous fusions; 5) tumors; 6) inflammatory disorders; 7) spinal degeneration, 8) facet degeneration with instability; and 9) reconstruction following…
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| K254045 | CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…NKG · Traditional | CarboFix Orthopedics , Ltd. | 03/16/2026SE |
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| K253129 | Infinity OCT SystemNKG · Special | Medtronic Sofamor Danek USA, Inc. | 10/24/2025SE |
| K251725 | ANAX OCT Spinal SystemNKG · Special | Cg Medtech Co., Ltd. | 06/25/2025SE |
| K250866 | Sovereign Posterior Cervical SystemNKG · Traditional | Met One Technologies, LLC | 05/20/2025SE |
| K242674 | Freedom Posterior Cervical ScrewsNKG · Traditional | Signature Orthopaedics Pty, Ltd. | 05/13/2025SE |
| K250332 | Virage® OCT Spinal Fixation SystemNKG · Traditional | Highridge Medical, LLC | 04/04/2025SE |
| K242516 | EUROPA Posterior Cervical Fusion SystemNKG · Traditional | MiRus, LLC | 11/19/2024SE |
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| K253966 | PERLA® TL Posterior Thoraco-lumbar Fixation SystemNKB · Traditional | 05/01/2026SE |
| K254158 | SPINEART Navigation Instrument SystemOLO · Special | 04/09/2026SE |
| K242933 | SPINEART Navigation Instrument SystemOLO · Traditional | 06/18/2025SE |
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| K242589 | Scarlet® AL-TMAX · Traditional | 10/23/2024SE |
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| K241321 | Juliet® Ti LL Lumbar Interbody DeviceOVD · Traditional | 07/18/2024SE |
Questions and answers
When was Perla® Posterior Cervico-Thoracic Fixation System cleared by the FDA?
Perla® Posterior Cervico-Thoracic Fixation System (K190071) received a 510(k) decision of Substantially Equivalent on February 25, 2019, 41 days after the submission was received.
What is the product code of K190071?
The FDA product code is NKG – Posterior Cervical Screw System, a Class II (moderate risk) device regulated under 21 CFR 888.3075.