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FDA 510(k)

MODEL 3000 AXYALOOP BIO-ABSORBABLE BONE ANCHOR

K-Number: K051983 · 2005-08-05

ApplicantAxya Medical, Inc.
Decision Date2005-08-05
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MODEL 3000 AXYALOOP BIO-ABSORBABLE BONE ANCHOR is the device name listed in this FDA 510(k) record. The listed applicant is Axya Medical, Inc.. It received FDA 510(k) clearance on 2005-08-05 under 510(k) number K051983. The device is classified under product code MAI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL 3000 AXYALOOP BIO-ABSORBABLE BONE ANCHOR?

MODEL 3000 AXYALOOP BIO-ABSORBABLE BONE ANCHOR is a medical device that received FDA 510(k) clearance on 2005-08-05. The listed applicant is Axya Medical, Inc.. The 510(k) number is K051983.

When did MODEL 3000 AXYALOOP BIO-ABSORBABLE BONE ANCHOR receive FDA 510(k) clearance?

MODEL 3000 AXYALOOP BIO-ABSORBABLE BONE ANCHOR received FDA 510(k) clearance on 2005-08-05, under 510(k) number K051983.

Who is the listed applicant for MODEL 3000 AXYALOOP BIO-ABSORBABLE BONE ANCHOR?

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

What is the FDA product code for MODEL 3000 AXYALOOP BIO-ABSORBABLE BONE ANCHOR?

The FDA product code for MODEL 3000 AXYALOOP BIO-ABSORBABLE BONE ANCHOR is MAI.

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Other records listing Axya Medical, 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.

K070773AXYA, MODEL 3000 AXYZLOOP TITANIUM BONE ANCHORK070253AXYA SUTURE WELDING SYSTEM AND KITK063194TUFFLEX POLYESTER SUTUREK060165AXYAFLEX POLYESTER SUTUREK060970AXYALOOP NONABSORBABLE BONE ANCHORK052491AXYA MODEL 6500 AXYALOOP SELF-TAPPING BONE ANCHOR

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Related Devices (Code: MAI)

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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