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FDA 510(k)

ORTHOPEDIATRICS BONE SCREWS

K-Number: K082949 · 2008-11-25

ApplicantOrthoPediatrics Corp.
Decision Date2008-11-25
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ORTHOPEDIATRICS BONE SCREWS is the device name listed in this FDA 510(k) record. The listed applicant is OrthoPediatrics Corp.. It received FDA 510(k) clearance on 2008-11-25 under 510(k) number K082949. 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 ORTHOPEDIATRICS BONE SCREWS?

ORTHOPEDIATRICS BONE SCREWS is a medical device that received FDA 510(k) clearance on 2008-11-25. The listed applicant is OrthoPediatrics Corp.. The 510(k) number is K082949.

When did ORTHOPEDIATRICS BONE SCREWS receive FDA 510(k) clearance?

ORTHOPEDIATRICS BONE SCREWS received FDA 510(k) clearance on 2008-11-25, under 510(k) number K082949.

Who is the listed applicant for ORTHOPEDIATRICS BONE SCREWS?

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

What is the FDA product code for ORTHOPEDIATRICS BONE SCREWS?

The FDA product code for ORTHOPEDIATRICS BONE SCREWS is HWC. This falls under the Cardiovascular category.

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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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