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FDA 510(k)

OTI BONE CEMENT PLUG

K-Number: K030608 · 2003-06-12

ApplicantOsteoimplant Technology, Inc.
Decision Date2003-06-12
Product CodeJDK
Advisory CommitteeSU
DecisionUnknown

Device Summary

OTI BONE CEMENT PLUG is the device name listed in this FDA 510(k) record. The listed applicant is Osteoimplant Technology, Inc.. It received FDA 510(k) clearance on 2003-06-12 under 510(k) number K030608. The device is classified under product code JDK. It was reviewed by the SU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the OTI BONE CEMENT PLUG?

OTI BONE CEMENT PLUG is a medical device that received FDA 510(k) clearance on 2003-06-12. The listed applicant is Osteoimplant Technology, Inc.. The 510(k) number is K030608.

When did OTI BONE CEMENT PLUG receive FDA 510(k) clearance?

OTI BONE CEMENT PLUG received FDA 510(k) clearance on 2003-06-12, under 510(k) number K030608.

Who is the listed applicant for OTI BONE CEMENT PLUG?

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

What is the FDA product code for OTI BONE CEMENT PLUG?

The FDA product code for OTI BONE CEMENT PLUG is JDK.

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Other records listing Osteoimplant Technology, Inc. as applicant

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Related Devices (Code: JDK)

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.

K210062Mectaplug PE IIMedacta International S.A.K061465KMI CEMENT RESTRICTOR IMPLANTKinetikos Medical, Inc.K061698MODIFICATION TO LIFE SPINE CEMENT RESTRICTORLife SpineK060247LIFE SPINE CEMENT RESTRICTORLife SpineK060132SPINAL USA CEMENT RESTRICTOR SYSTEMSpinal USAK051371INTERBODY INNOVATIONS CEMENT RESTRICTORInterbody Innovations, Llp

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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