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FDA 510(k)

MITEK BTB ABSORBABLE (PLA) CROSS PIN

K-Number: K974341 · 1998-04-16

ApplicantMitek Products
Decision Date1998-04-16
Product CodeHTY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MITEK BTB ABSORBABLE (PLA) CROSS PIN is the device name listed in this FDA 510(k) record. The listed applicant is Mitek Products. It received FDA 510(k) clearance on 1998-04-16 under 510(k) number K974341. The device is classified under product code HTY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MITEK BTB ABSORBABLE (PLA) CROSS PIN?

MITEK BTB ABSORBABLE (PLA) CROSS PIN is a medical device that received FDA 510(k) clearance on 1998-04-16. The listed applicant is Mitek Products. The 510(k) number is K974341.

When did MITEK BTB ABSORBABLE (PLA) CROSS PIN receive FDA 510(k) clearance?

MITEK BTB ABSORBABLE (PLA) CROSS PIN received FDA 510(k) clearance on 1998-04-16, under 510(k) number K974341.

Who is the listed applicant for MITEK BTB ABSORBABLE (PLA) CROSS PIN?

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

What is the FDA product code for MITEK BTB ABSORBABLE (PLA) CROSS PIN?

The FDA product code for MITEK BTB ABSORBABLE (PLA) CROSS PIN is HTY.

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Other records listing Mitek Products 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.

K013572MITEK BIOCRYL INTERFERENCE SCREWSK013781RIDIDFIX 2.7MM BTB CROSS PIN KITK002639BIOKNOTLESS ANCHORK010633RIGIDFIX SOFT TISSUE ACL CROSSPIN SYSTEMK002406MITEK 2GII MENISCAL REPAIR SYSTEMK003076MITEK CUFFTACK

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Related Devices (Code: HTY)

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

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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