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FDA 510(k)

ORTHOPEDIC DEVICES

K-Number: K780235 · 1978-02-23

ApplicantBiomet, Inc.
Decision Date1978-02-23
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ORTHOPEDIC DEVICES is the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 1978-02-23 under 510(k) number K780235. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORTHOPEDIC DEVICES?

ORTHOPEDIC DEVICES is a medical device that received FDA 510(k) clearance on 1978-02-23. The listed applicant is Biomet, Inc.. The 510(k) number is K780235.

When did ORTHOPEDIC DEVICES receive FDA 510(k) clearance?

ORTHOPEDIC DEVICES received FDA 510(k) clearance on 1978-02-23, under 510(k) number K780235.

Who is the listed applicant for ORTHOPEDIC DEVICES?

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

What is the FDA product code for ORTHOPEDIC DEVICES?

The FDA product code for ORTHOPEDIC DEVICES is HWC. This falls under the Cardiovascular category.

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Related PubMed Literature

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.

PMID: 40157338FDA regulatory considerations for innovative orthopedic devices: A review.Injury ()

Other records listing Biomet, 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.

K253434OSSTM Orthopedic Salvage SystemK251270Taperloc® Complete Hip StemK241014Biomet Kirschner Wires (K-Wires)K222760StageOne™ Select Hip Cement Spacer MoldsK221968StageOne™ Shoulder Cement Spacer MoldsK213287StageOne Knee Cement Spacer Molds

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Related Devices (Code: HWC)

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.

K262975Arthrex Beaming SystemArthrex, Inc.K260995DynaNail Helix® Fixation SystemMedShape, Inc.K254280F.A.S.T ScrewSteps OrthoK261057ActivaScrew™ Cannulated COMBioretec, Ltd.K260106OsteoCoil™ GT Active Compression SystemFlower Orthopedics Corporation DBA Conventus Flower OrthopedK262344Large Compression ScrewsTriMed, Inc.

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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