FDA 510(k)

Patient Specific Marking Guides

K-Number: K211076 · 2022-06-28

Decision Date2022-06-28

Product CodePBF

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Patient Specific Marking Guides is the device name listed in this FDA 510(k) record. The listed applicant is Additive Orthopaedics, LLC. It received FDA 510(k) clearance on 2022-06-28 under 510(k) number K211076. The device is classified under product code PBF. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Patient Specific Marking Guides?

Patient Specific Marking Guides is a medical device that received FDA 510(k) clearance on 2022-06-28. The listed applicant is Additive Orthopaedics, LLC. The 510(k) number is K211076.

When did Patient Specific Marking Guides receive FDA 510(k) clearance?

Patient Specific Marking Guides received FDA 510(k) clearance on 2022-06-28, under 510(k) number K211076.

Who is the listed applicant for Patient Specific Marking Guides?

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

What is the FDA product code for Patient Specific Marking Guides?

The FDA product code for Patient Specific Marking Guides is PBF.

Other records listing Additive Orthopaedics, LLC 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.

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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.