OFFICIAL OPENFDA FEI RECORDFEI: 3015542154Reg Yr: 2027South Korea (KR)

Zimmer Biomet Korea Ltd.

Official US Food and Drug Administration (FDA) Establishment Registration & Device/Facility Listing dossier for Zimmer Biomet Korea Ltd. (FEI 3015542154). Use this record to cross-check CBP ACE Affirmation of Compliance codes (`DEV` / `DFE` / `FEI`), verify the designated US Agent on file, and subscribe to automated Import Alert (DWPE) monitoring.

Registered Facility Address

5F, Ilshin Building, 98 Hannamdae-ro, Yongsan-gu

Seoul, South Korea (04418)

FDA FURLS Identifiers

FEI Number: 3015542154

Registration No: 3015542154 • Status Code: 1 (Active)

Designated U.S. Agent21 CFR 807.40

Stephanie Lynch

Zimmer Biomet

Warsaw, IN (USA)

715-9289253

Stephanie.Lynch@zimmerbiomet.com

Registered FDA Product Codes, Device Classes & Commercial Names

Cross-check your commercial invoice product descriptions against these active FDA product code filings to prevent NO_510K or UNAPPROVED_NEW_DRUG port holds.

Product Code	FDA Classification Name	Device Class	21 CFR Regulation	510(k) Exempt?
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Class 2	21 CFR 888.3030	Requires 510(k) / Check

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Get an automated Slack/Webhook JSON payload and email alert within 15 minutes whenever FDA OASIS logs a new detention, Import Alert Red List addition, or Warning Letter for Zimmer Biomet Korea Ltd. (FEI 3015542154) before you wire your 70% balance payment.

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Shipment Detained by FDA or Placed on Import Alert? Request Free 24h Detention Evaluation from Licensed US FDA Compliance Counsel

When FDA issues a Notice of FDA Action (Detention), importers typically have only 10 to 20 business days to file a Form FDA 766 relabeling application, submit an accredited private laboratory packet (PLAP), or petition for Import Alert Red List removal before CBP orders refusal and liquidated damages.

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Importer Website or Amazon/Shopify Store URL (Required)

Include https:// so counsel can pre-screen product Intended Use claims.

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CBP Entry Number or Supplier FEI # (Required)

Format: 10-digit FEI (e.g., 3015542154) or 11-char CBP Entry # (e.g., W94-8829104-3).

Enter a 5–24 character alphanumeric FEI number or CBP Entry number.

US Port of Detention

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Primary Cited FDA Charge Code

Charge listed on your Notice of FDA Action.

Commercial Cargo Value at Risk

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Notice of FDA Action Summary & Respond-By Date (Optional)

Describe whether cargo is currently on hold in ITACS, whether private lab sampling has started, or if you need an Import Alert removal petition.

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Frequently Asked Questions: FEI 3015542154 (Zimmer Biomet Korea Ltd.)

What is the FDA FEI Number for Zimmer Biomet Korea Ltd.?

According to public US FDA Establishment Registration records, Zimmer Biomet Korea Ltd. (Seoul, South Korea) is assigned FDA Facility Establishment Identifier (FEI) 3015542154 (Registration No. 3015542154) with registration year 2027.

Who is the designated US Agent for FEI 3015542154 (Zimmer Biomet Korea Ltd.)?

The registered US Agent on file for FEI 3015542154 is Stephanie Lynch (Zimmer Biomet) located in Warsaw, IN. Importers should independently confirm active representation before filing CBP ACE entry.

Does an active FDA FEI registration guarantee that shipments from Zimmer Biomet Korea Ltd. will clear US Customs without detention?

No. An active FDA FEI number or establishment registration only confirms administrative listing in FDA FURLS. Shipments can still be detained at US ports under Detention Without Physical Examination (DWPE / Import Alerts) for labeling, 510(k), cGMP, or adulteration violations.