Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Integrity Implants Navigated Instruments

K-Number: K212088 · 2021-12-23

ApplicantIntegrity Implants, Inc.
Decision Date2021-12-23
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Integrity Implants Navigated Instruments is a medical device manufactured by Integrity Implants, Inc.. It received FDA 510(k) clearance on 2021-12-23 under approval number K212088. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Integrity Implants Navigated Instruments?

Integrity Implants Navigated Instruments is a medical device that received FDA 510(k) clearance on 2021-12-23. It is manufactured by Integrity Implants, Inc.. The 510(k) number is K212088.

When was Integrity Implants Navigated Instruments approved by the FDA?

Integrity Implants Navigated Instruments received FDA 510(k) clearance on 2021-12-23, under approval number K212088.

What company makes Integrity Implants Navigated Instruments?

Integrity Implants Navigated Instruments is manufactured by Integrity Implants, Inc..

What is the FDA product code for Integrity Implants Navigated Instruments?

The FDA product code for Integrity Implants Navigated Instruments is OLO.

Related Clinical Trials

NCT07212855 Use of Glycine Powder and an Angled Implant Brush in Oral Hygiene Procedures in Patients Rehabilitated With Columbus Bridge Protocol COMPLETED

Related PubMed Literature

PMID: 40528079 The Challenges in the Regulatory Approval of Additive-Manufactured Medical Devices: A Quantitative Survey. Therapeutic innovation & regulatory science (2025)

Other Devices by Integrity Implants, Inc.

K190360LineSider™ Spinal System K183184FlareHawk Interbody Fusion System K182114FlareHawk Interbody Fusion System K203367LineSider™ Spinal System K202198FlareHawk Interbody Fusion System K201367FlareHawk TiHawk9 Interbody Fusion System

View all 11 devices →

Related Devices (Code: OLO)

K162375Envision 3D: Image Guidance System7D Surgical, Inc. K162341Stryker OrthoMap Precision Knee systemStryker Leibinger GmbH & Co KG K162195TSolution One Cup1 Surgical SystemTHINK Surgical, Inc. K160385Precision ScrewCryptych Pty, Ltd. K153700Aesculap(R) Implant Systems (AIS) S4 Navigation InstrumentsAesculap Implant Systems, LLC K153240Styrker OrthoMap Express Knee SystemStryker Corporate

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.

↑