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FDA 510(k)

OSSTAPLE CHILL

K-Number: K102107 · 2010-09-03

ApplicantBiomedical Ent., Inc.
Decision Date2010-09-03
Product CodeJDR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OSSTAPLE CHILL is the device name listed in this FDA 510(k) record. The listed applicant is Biomedical Ent., Inc.. It received FDA 510(k) clearance on 2010-09-03 under 510(k) number K102107. The device is classified under product code JDR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OSSTAPLE CHILL?

OSSTAPLE CHILL is a medical device that received FDA 510(k) clearance on 2010-09-03. The listed applicant is Biomedical Ent., Inc.. The 510(k) number is K102107.

When did OSSTAPLE CHILL receive FDA 510(k) clearance?

OSSTAPLE CHILL received FDA 510(k) clearance on 2010-09-03, under 510(k) number K102107.

Who is the listed applicant for OSSTAPLE CHILL?

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

What is the FDA product code for OSSTAPLE CHILL?

The FDA product code for OSSTAPLE CHILL is JDR.

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Other records listing Biomedical Ent., 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.

K131640SMOOTH OR THREADED METALLIC BONE FASTENERK091951HAMMERLOCKK023203OSSTAPLEK001354MEMOGRAPH; OSSTAPLE - ORTHOPEDIC USES FOR SMALL BONE AND FRAGMENT FIXATION FOR THE MEMOGRAPH STAPLE SYSTEMK001353MEMOGRAPH; OSSTAPLE - NEUROSURGICAL USES FOR CRANIOFACIAL FRACTURES AND CRANIOPLASTY FOR THE MEMOGRAPH STAPLE SYSTEMK001219MEMOGRAPH; OSSTAPLE - ORAL AND MAXILLIOFACIAL PROCEDURES FOR THE MEMOGRAPH STAPLE SYSTEM

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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.

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