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FDA 510(k)

PONTIS SUTURES AND SUTURE ANCHORS WITH OPTIONAL CRIMPS

K-Number: K101126 · 2010-12-02

ApplicantCore Essence Orthopaedics, Inc.
Decision Date2010-12-02
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PONTIS SUTURES AND SUTURE ANCHORS WITH OPTIONAL CRIMPS is the device name listed in this FDA 510(k) record. The listed applicant is Core Essence Orthopaedics, Inc.. It received FDA 510(k) clearance on 2010-12-02 under 510(k) number K101126. 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 PONTIS SUTURES AND SUTURE ANCHORS WITH OPTIONAL CRIMPS?

PONTIS SUTURES AND SUTURE ANCHORS WITH OPTIONAL CRIMPS is a medical device that received FDA 510(k) clearance on 2010-12-02. The listed applicant is Core Essence Orthopaedics, Inc.. The 510(k) number is K101126.

When did PONTIS SUTURES AND SUTURE ANCHORS WITH OPTIONAL CRIMPS receive FDA 510(k) clearance?

PONTIS SUTURES AND SUTURE ANCHORS WITH OPTIONAL CRIMPS received FDA 510(k) clearance on 2010-12-02, under 510(k) number K101126.

Who is the listed applicant for PONTIS SUTURES AND SUTURE ANCHORS WITH OPTIONAL CRIMPS?

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

What is the FDA product code for PONTIS SUTURES AND SUTURE ANCHORS WITH OPTIONAL CRIMPS?

The FDA product code for PONTIS SUTURES AND SUTURE ANCHORS WITH OPTIONAL CRIMPS is MBI.

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Other records listing Core Essence Orthopaedics, 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.

K090128TAC-TITE (TM)

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.

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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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