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FDA 510(k)

Adena-Zina Spinal System

K-Number: K231931 · 2023-07-28

ApplicantShanghai Sanyou Medical Co, Ltd.
Decision Date2023-07-28
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Adena-Zina Spinal System is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Sanyou Medical Co, Ltd.. It received FDA 510(k) clearance on 2023-07-28 under 510(k) number K231931. 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 Adena-Zina Spinal System?

Adena-Zina Spinal System is a medical device that received FDA 510(k) clearance on 2023-07-28. The listed applicant is Shanghai Sanyou Medical Co, Ltd.. The 510(k) number is K231931.

When did Adena-Zina Spinal System receive FDA 510(k) clearance?

Adena-Zina Spinal System received FDA 510(k) clearance on 2023-07-28, under 510(k) number K231931.

Who is the listed applicant for Adena-Zina Spinal System?

The FDA 510(k) record lists Shanghai Sanyou Medical Co, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Adena-Zina Spinal System?

The FDA product code for Adena-Zina Spinal System is NKB.

Other records listing Shanghai Sanyou Medical Co, Ltd. 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.

K230872Halis™ Lumbar Cage System, Lydia™ Anterior Lumbar Fusion System, Dica™ Direction Changeable Lumbar Cage System, KEYSTONE Cage SystemK230961Zeus Spinal SystemK211689KEYSTONE PEEK Cage SystemK212066Adena-Zina SystemK163366Shanghai Sanyou CARMEN Cervical Fusion SystemK163422Shanghai Sanyou PEEK Cage System

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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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