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FDA 510(k)

GAP ENDO-EXO MEDULLARY SYSTEM

K-Number: K111232 · 2012-01-26

ApplicantPega Medical, Inc.
Decision Date2012-01-26
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

GAP ENDO-EXO MEDULLARY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Pega Medical, Inc.. It received FDA 510(k) clearance on 2012-01-26 under 510(k) number K111232. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GAP ENDO-EXO MEDULLARY SYSTEM?

GAP ENDO-EXO MEDULLARY SYSTEM is a medical device that received FDA 510(k) clearance on 2012-01-26. The listed applicant is Pega Medical, Inc.. The 510(k) number is K111232.

When did GAP ENDO-EXO MEDULLARY SYSTEM receive FDA 510(k) clearance?

GAP ENDO-EXO MEDULLARY SYSTEM received FDA 510(k) clearance on 2012-01-26, under 510(k) number K111232.

Who is the listed applicant for GAP ENDO-EXO MEDULLARY SYSTEM?

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

What is the FDA product code for GAP ENDO-EXO MEDULLARY SYSTEM?

The FDA product code for GAP ENDO-EXO MEDULLARY SYSTEM is HSB.

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Other records listing Pega Medical, Inc. as applicant

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Related Devices (Code: HSB)

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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