Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Pisces Spinal System

K-Number: K203023 · 2021-07-14

ApplicantOrtho Development Corporation
Decision Date2021-07-14
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Pisces Spinal System is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Development Corporation. It received FDA 510(k) clearance on 2021-07-14 under 510(k) number K203023. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Pisces Spinal System?

Pisces Spinal System is a medical device that received FDA 510(k) clearance on 2021-07-14. The listed applicant is Ortho Development Corporation. The 510(k) number is K203023.

When did Pisces Spinal System receive FDA 510(k) clearance?

Pisces Spinal System received FDA 510(k) clearance on 2021-07-14, under 510(k) number K203023.

Who is the listed applicant for Pisces Spinal System?

The FDA 510(k) record lists Ortho Development Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Pisces Spinal System?

The FDA product code for Pisces Spinal System is NKB.

Other records listing Ortho Development Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253161Balanced Knee System TriMax Porous Femoral ComponentsK251052Trivicta® Hip StemK242984BKS Revision SystemK242833Legend® Acetabular ShellK233758Trivicta™ Hip StemK233093Balanced Knee® System TriMax PS Plus Tibial Insert

View all 18 devices →

Related Devices (Code: NKB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260362QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration)MANTIZ Co., Ltd.K253943Tiger 2 SystemZavation Medical Products, LLCK261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.OK253045“Socko” Vimax Spinal Fixation SystemSocko Medical Co., Ltd.K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑