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FDA 510(k)

Erisma® Lp Spinal Fixation System; Erisma® LP MIS

K-Number: K241863 · 2024-07-24

ApplicantClariance
Decision Date2024-07-24
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Erisma® Lp Spinal Fixation System; Erisma® LP MIS is the device name listed in this FDA 510(k) record. The listed applicant is Clariance. It received FDA 510(k) clearance on 2024-07-24 under 510(k) number K241863. 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 Erisma® Lp Spinal Fixation System; Erisma® LP MIS?

Erisma® Lp Spinal Fixation System; Erisma® LP MIS is a medical device that received FDA 510(k) clearance on 2024-07-24. The listed applicant is Clariance. The 510(k) number is K241863.

When did Erisma® Lp Spinal Fixation System; Erisma® LP MIS receive FDA 510(k) clearance?

Erisma® Lp Spinal Fixation System; Erisma® LP MIS received FDA 510(k) clearance on 2024-07-24, under 510(k) number K241863.

Who is the listed applicant for Erisma® Lp Spinal Fixation System; Erisma® LP MIS?

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

What is the FDA product code for Erisma® Lp Spinal Fixation System; Erisma® LP MIS?

The FDA product code for Erisma® Lp Spinal Fixation System; Erisma® LP MIS is NKB.

Other records listing Clariance 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.

K243904Elegance® Anterior Cervical plateK243670Idys® LIFK240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemK240715Idys® C ZP 3DTiK220182Aggeris™-CK212562Idys-C ZP 3DTi

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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.

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