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FDA 510(k)

MEMOGRAPH; OSSTAPLE - NEUROSURGICAL USES FOR CRANIOFACIAL FRACTURES AND CRANIOPLASTY FOR THE MEMOGRAPH STAPLE SYSTEM

K-Number: K001353 · 2001-03-13

ApplicantBiomedical Ent., Inc.
Decision Date2001-03-13
Product CodeHBW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MEMOGRAPH; OSSTAPLE - NEUROSURGICAL USES FOR CRANIOFACIAL FRACTURES AND CRANIOPLASTY FOR THE MEMOGRAPH STAPLE SYSTEM 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 2001-03-13 under 510(k) number K001353. The device is classified under product code HBW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEMOGRAPH; OSSTAPLE - NEUROSURGICAL USES FOR CRANIOFACIAL FRACTURES AND CRANIOPLASTY FOR THE MEMOGRAPH STAPLE SYSTEM?

MEMOGRAPH; OSSTAPLE - NEUROSURGICAL USES FOR CRANIOFACIAL FRACTURES AND CRANIOPLASTY FOR THE MEMOGRAPH STAPLE SYSTEM is a medical device that received FDA 510(k) clearance on 2001-03-13. The listed applicant is Biomedical Ent., Inc.. The 510(k) number is K001353.

When did MEMOGRAPH; OSSTAPLE - NEUROSURGICAL USES FOR CRANIOFACIAL FRACTURES AND CRANIOPLASTY FOR THE MEMOGRAPH STAPLE SYSTEM receive FDA 510(k) clearance?

MEMOGRAPH; OSSTAPLE - NEUROSURGICAL USES FOR CRANIOFACIAL FRACTURES AND CRANIOPLASTY FOR THE MEMOGRAPH STAPLE SYSTEM received FDA 510(k) clearance on 2001-03-13, under 510(k) number K001353.

Who is the listed applicant for MEMOGRAPH; OSSTAPLE - NEUROSURGICAL USES FOR CRANIOFACIAL FRACTURES AND CRANIOPLASTY FOR THE MEMOGRAPH STAPLE SYSTEM?

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 MEMOGRAPH; OSSTAPLE - NEUROSURGICAL USES FOR CRANIOFACIAL FRACTURES AND CRANIOPLASTY FOR THE MEMOGRAPH STAPLE SYSTEM?

The FDA product code for MEMOGRAPH; OSSTAPLE - NEUROSURGICAL USES FOR CRANIOFACIAL FRACTURES AND CRANIOPLASTY FOR THE MEMOGRAPH STAPLE SYSTEM is HBW.

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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 FASTENERK102107OSSTAPLE CHILLK091951HAMMERLOCKK023203OSSTAPLEK001354MEMOGRAPH; OSSTAPLE - ORTHOPEDIC USES FOR SMALL BONE AND FRAGMENT FIXATION FOR THE MEMOGRAPH STAPLE SYSTEMK001219MEMOGRAPH; OSSTAPLE - ORAL AND MAXILLIOFACIAL PROCEDURES FOR THE MEMOGRAPH STAPLE SYSTEM

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Related Devices (Code: HBW)

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

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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