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FDA 510(k)

BONE-TEMNO/STERNUM-TEMNO

K-Number: K913306 · 1991-11-01

ApplicantProact, Ltd.
Decision Date1991-11-01
Product CodeLWE
DecisionSubstantially Equivalent

Device Summary

BONE-TEMNO/STERNUM-TEMNO is the device name listed in this FDA 510(k) record. The listed applicant is Proact, Ltd.. It received FDA 510(k) clearance on 1991-11-01 under 510(k) number K913306. The device is classified under product code LWE. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BONE-TEMNO/STERNUM-TEMNO?

BONE-TEMNO/STERNUM-TEMNO is a medical device that received FDA 510(k) clearance on 1991-11-01. The listed applicant is Proact, Ltd.. The 510(k) number is K913306.

When did BONE-TEMNO/STERNUM-TEMNO receive FDA 510(k) clearance?

BONE-TEMNO/STERNUM-TEMNO received FDA 510(k) clearance on 1991-11-01, under 510(k) number K913306.

Who is the listed applicant for BONE-TEMNO/STERNUM-TEMNO?

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

What is the FDA product code for BONE-TEMNO/STERNUM-TEMNO?

The FDA product code for BONE-TEMNO/STERNUM-TEMNO is LWE.

Related Clinical Trials

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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Other records listing Proact, 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.

K941256QUICK CORE IIK926559PROACT BIOPSY NEEDLE ENCHANCEMENTSK902320BAUER FLEXI-TEMNO BIOPSY NEEDLEK902319BAUER TEMNO BIOPSY NEEDLE

Related Devices (Code: LWE)

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.

K952350JAMSHIDI STYLE BIOPSY NEEDLE (ACRI) (BIOMID), ILLINOIS STYLE BIOPSY NEEDLE (ISAN)Promedical , Ltd.K871198BONE MARROW COLLECTION KIT AND STANDBaxter Healthcare Corp

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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