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FDA 510(k)

STERLING INTERFERENC SCREW HT

K-Number: K052405 · 2005-11-16

ApplicantRegeneration Technologies, Inc.
Decision Date2005-11-16
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

STERLING INTERFERENC SCREW HT 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 2005-11-16 under 510(k) number K052405. 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 INTERFERENC SCREW HT?

STERLING INTERFERENC SCREW HT is a medical device that received FDA 510(k) clearance on 2005-11-16. The listed applicant is Regeneration Technologies, Inc.. The 510(k) number is K052405.

When did STERLING INTERFERENC SCREW HT receive FDA 510(k) clearance?

STERLING INTERFERENC SCREW HT received FDA 510(k) clearance on 2005-11-16, under 510(k) number K052405.

Who is the listed applicant for STERLING INTERFERENC SCREW HT?

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 INTERFERENC SCREW HT?

The FDA product code for STERLING INTERFERENC SCREW HT 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.

View all 11 devices →

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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