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NY R03127




January 26, 2006

CLA-2-30:RR:NC:2:238 R03127

CATEGORY: CLASSIFICATION

TARIFF NO.: 3004.90.9190

Mr. Matthew Piccirilli
Stryker Biotech
35 South Street
Hopkinton, MA 01748

RE: The tariff classification of Calstrux™ from Ireland

Dear Mr. Piccirilli:

In your letter dated January 18, 2006, you requested a tariff classification ruling.

The subject product, Calstrux™, formerly known as Stryker® TCP Putty (see New York Ruling Letter R01013, dated November 9, 2004), is a bone-void filler that is used as a graft extender for both acute and delayed/non-union fractures, total joint revisions, and spine fusions. In its condition as imported, the product consists of granules composed of a mixture of porous beta-tricalcium phosphate (β-TCP) and carboxymethylcellulose sodium (CMC). Prior to actual use (i.e., subsequent to importation), the product is reconstituted with saline or water for injection (WFI) to form a putty-type mass, which provides improved handling properties and retention at the implant site. Calstrux™ is intended to be gently packed into bony voids or gaps of the skeletal system (e.g., the extremities, spine, and pelvis). Following placement in the bony void or gap, the tricalcium phosphate “scaffold” is resorbed, and replaced with bone during the healing process. [The CMC provides temporary (~24 hrs.) cohesive properties during handling and implantation, and is replaced by blood.] Calstrux™ is supplied in (measured-dose) quantities of 5cc, 10cc, or 15cc, put up in small bottles with removable caps.

The applicable subheading for Calstrux™, imported put up in small bottles in the aforementioned (measured-dose) quantities, will be 3004.90.9190, Harmonized Tariff of the United States (HTSUS), which provides for “Medicaments consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses (including those in the form of transdermal administration systems) or in forms or packings for retail sale: Other: Other: Other: Other.” The rate of duty will be free.

Duty rates are provided for your convenience and are subject to change. The text of the most recent HTSUS and the accompanying duty rates are provided on World Wide Web at http://www.usitc.gov/tata/hts/.

This merchandise may be subject to the requirements of the Federal Food, Drug, and Cosmetic Act, which are administered by the U.S. Food and Drug Administration. You may contact them at 5600 Fishers Lane, Rockville, Maryland 20857, telephone number 1-888-443-6332.

This ruling is being issued under the provisions of Part 177 of the Customs Regulations (19 C.F.R. 177).

A copy of the ruling or the control number indicated above should be provided with the entry documents filed at the time this merchandise is imported. If you have any questions regarding the ruling, contact National Import Specialist Harvey Kuperstein at 646-733-3033.

Sincerely,

Robert B. Swierupski

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