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FDA 510(k)

RESORBABLE INTERFERENCE SCREW

K-Number: K041274 · 2004-07-28

ApplicantArthrotek, Inc.
Decision Date2004-07-28
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

RESORBABLE INTERFERENCE SCREW is the device name listed in this FDA 510(k) record. The listed applicant is Arthrotek, Inc.. It received FDA 510(k) clearance on 2004-07-28 under 510(k) number K041274. 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 RESORBABLE INTERFERENCE SCREW?

RESORBABLE INTERFERENCE SCREW is a medical device that received FDA 510(k) clearance on 2004-07-28. The listed applicant is Arthrotek, Inc.. The 510(k) number is K041274.

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

RESORBABLE INTERFERENCE SCREW received FDA 510(k) clearance on 2004-07-28, under 510(k) number K041274.

Who is the listed applicant for RESORBABLE INTERFERENCE SCREW?

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

What is the FDA product code for RESORBABLE INTERFERENCE SCREW?

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

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Other records listing Arthrotek, Inc. as applicant

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K061776ARTHROTEK MAXFIRE MENISCAL REPAIR DEVICEK0618012.8 & 3.5MM LACTOSCREW SUTURE ANCHORSK061657HITCH LACTOSORB SUTURE ANCHORK061389ALLTHREAD LACTOSORB SUTURE ANCHORK060693MICROSTRIKE AND ALLTHREAD PEEK SUTURE ANCHORK053461EZLOC FEMORAL FIXATION DEVICE

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Related Devices (Code: HWC)

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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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