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FDA 510(k)

IMSE P-TLIF

K-Number: K130506 · 2013-05-13

ApplicantInstitute of Musculoskeletal Science & Education
Decision Date2013-05-13
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

IMSE P-TLIF is the device name listed in this FDA 510(k) record. The listed applicant is Institute of Musculoskeletal Science & Education. It received FDA 510(k) clearance on 2013-05-13 under 510(k) number K130506. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMSE P-TLIF?

IMSE P-TLIF is a medical device that received FDA 510(k) clearance on 2013-05-13. The listed applicant is Institute of Musculoskeletal Science & Education. The 510(k) number is K130506.

When did IMSE P-TLIF receive FDA 510(k) clearance?

IMSE P-TLIF received FDA 510(k) clearance on 2013-05-13, under 510(k) number K130506.

Who is the listed applicant for IMSE P-TLIF?

The FDA 510(k) record lists Institute of Musculoskeletal Science & Education as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IMSE P-TLIF?

The FDA product code for IMSE P-TLIF is MAX.

Related Devices (Code: MAX)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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