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FDA 510(k)

URESIL T-SYSTEM BONE SCREWS

K-Number: K870141 · 1987-02-03

ApplicantUresil Corp.
Decision Date1987-02-03
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

URESIL T-SYSTEM BONE SCREWS is the device name listed in this FDA 510(k) record. The listed applicant is Uresil Corp.. It received FDA 510(k) clearance on 1987-02-03 under 510(k) number K870141. 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 URESIL T-SYSTEM BONE SCREWS?

URESIL T-SYSTEM BONE SCREWS is a medical device that received FDA 510(k) clearance on 1987-02-03. The listed applicant is Uresil Corp.. The 510(k) number is K870141.

When did URESIL T-SYSTEM BONE SCREWS receive FDA 510(k) clearance?

URESIL T-SYSTEM BONE SCREWS received FDA 510(k) clearance on 1987-02-03, under 510(k) number K870141.

Who is the listed applicant for URESIL T-SYSTEM BONE SCREWS?

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

What is the FDA product code for URESIL T-SYSTEM BONE SCREWS?

The FDA product code for URESIL T-SYSTEM BONE SCREWS is HWC. This falls under the Cardiovascular category.

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Other records listing Uresil Corp. 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.

K003753GP GENERAL PURPOSE DRAINAGE SET, MINI-PIGTAIL DRAINAGE CATHETER WITH LOCKING PIGTAIL, GP GENERAL PURPOSE DRAINAGE CATHEK980278URESIL VASCU-FLO INFUSION CATHETERK981344URESIL PERCUTANEOUS DRAINAGE CATHETERS WITH HYDROPHILIC COATINGK980282URESIL DILATOR WITH RADIOPAQUE MARKERK980889URESIL NEPHRO-URETERAL STENTK972582URESIL GUIDEWIRE

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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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