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FDA 510(k)

MICRO/MINI N-PK(H) BONE ANCHOR

K-Number: K121356 · 2012-11-09

ApplicantAnulex Technologies, Inc.
Decision Date2012-11-09
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MICRO/MINI N-PK(H) BONE ANCHOR is the device name listed in this FDA 510(k) record. The listed applicant is Anulex Technologies, Inc.. It received FDA 510(k) clearance on 2012-11-09 under 510(k) number K121356. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICRO/MINI N-PK(H) BONE ANCHOR?

MICRO/MINI N-PK(H) BONE ANCHOR is a medical device that received FDA 510(k) clearance on 2012-11-09. The listed applicant is Anulex Technologies, Inc.. The 510(k) number is K121356.

When did MICRO/MINI N-PK(H) BONE ANCHOR receive FDA 510(k) clearance?

MICRO/MINI N-PK(H) BONE ANCHOR received FDA 510(k) clearance on 2012-11-09, under 510(k) number K121356.

Who is the listed applicant for MICRO/MINI N-PK(H) BONE ANCHOR?

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

What is the FDA product code for MICRO/MINI N-PK(H) BONE ANCHOR?

The FDA product code for MICRO/MINI N-PK(H) BONE ANCHOR is MBI.

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Other records listing Anulex Technologies, Inc. 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.

K121354MICRO/MINI N-PK(F) BONE ANCHORK113805FIXATE TISSUE BANDK113400FIXATE TISSUE BANDK112849FIXATE TISSUE BANDK111462FIXATE TISSUE BANDK100572VERSACLOSE, MODEL VC-200-01

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Related Devices (Code: MBI)

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.

K261869Integrity Retractable Implant Inserter (6000127)Anika Therapeutics, Inc.K262809ArthroTAK Tendon Anchor KitArthroTAK, LLCK253065Aevumed SUPERCYNCH™ Button SystemAevumed, Inc.K262677Iconix Knotless TRiverpoint MedicalK262047Grappler Suture Anchor SystemParagon 28, Inc.K262369AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair Device, Curved DownStryker Endoscopy

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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