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FDA 510(k)

STERLING INTERFERENCE SCREW ST

K-Number: K050767 · 2005-06-09

ApplicantRegeneration Technologies, Inc.
Decision Date2005-06-09
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

STERLING INTERFERENCE SCREW ST is the device name listed in this FDA 510(k) record. The listed applicant is Regeneration Technologies, Inc.. It received FDA 510(k) clearance on 2005-06-09 under 510(k) number K050767. 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 STERLING INTERFERENCE SCREW ST?

STERLING INTERFERENCE SCREW ST is a medical device that received FDA 510(k) clearance on 2005-06-09. The listed applicant is Regeneration Technologies, Inc.. The 510(k) number is K050767.

When did STERLING INTERFERENCE SCREW ST receive FDA 510(k) clearance?

STERLING INTERFERENCE SCREW ST received FDA 510(k) clearance on 2005-06-09, under 510(k) number K050767.

Who is the listed applicant for STERLING INTERFERENCE SCREW ST?

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

What is the FDA product code for STERLING INTERFERENCE SCREW ST?

The FDA product code for STERLING INTERFERENCE SCREW ST is HWC. This falls under the Cardiovascular category.

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Other records listing Regeneration Technologies, 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.

K080418REGENAFIL, REGENAFORM, ALRIVA DBM PASTE, SLTIVA DM WITH CORTICAL CANCELLOUS SHIPS, BIOSET, SIOSET IC, RTI ALLOGRAFT PASTK072238BIOSET XCHK072327CANCELLO-PURE BONE WEDGE, 12MM EVANS OR 6MM COTTONK063584STERLING IF SCREW EYELET, MODEL CID3936 AND STERLING CROSS-PIN EYELET, MODEL CID3937K060180BIOSET XCK060253STERLING INTERFERENCE SCREW HT, STERLING INTERFERENCE SCREW ST.

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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