FDA 510(k)

EsTemp Implant

K-Number: K262983 · 2026-09-25

Decision Date2026-09-25

Product CodeEMA

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

EsTemp Implant is the device name listed in this FDA 510(k) record. The listed applicant is Spident Co., Ltd.. It received FDA 510(k) clearance on 2026-09-25 under 510(k) number K262983. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EsTemp Implant?

EsTemp Implant is a medical device that received FDA 510(k) clearance on 2026-09-25. The listed applicant is Spident Co., Ltd.. The 510(k) number is K262983.

When did EsTemp Implant receive FDA 510(k) clearance?

EsTemp Implant received FDA 510(k) clearance on 2026-09-25, under 510(k) number K262983.

Who is the listed applicant for EsTemp Implant?

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

What is the FDA product code for EsTemp Implant?

The FDA product code for EsTemp Implant is EMA.

Other records listing Spident 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.

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Official Source

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