510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Lincotek Medical LLC

Bartlett, TN, US

Lincotek Medical LLC appears in FDA device records in Bartlett, TN. FDA records list 2 510(k) clearances between and , no PMA records and 4 registered establishments. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
2
PMA records
0
Recall records
0
Registered establishments
4

510(k) clearance history

FDA records hold 2 510(k) clearances for Lincotek Medical LLC between 2025 and 2026. The busiest year on record is 2025, with 1. The most recent is 2026, with 1.

Clearances by year, as a table
510(k) clearance decisions for Lincotek Medical LLC, by decision year
YearClearances
20251
20261
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K252081SportLinc Syndesmosis DeviceHTNSubstantially Equivalent
K250764SpineLinc Anterior Cervical Implant SystemODPSubstantially Equivalent

Registered establishments

FDA registered establishments for Lincotek Medical LLC, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30207452363020745236LINCOTEK MEDICAL, LLC221 Commercial Parkway, Molalla, OR 97038 US2026
30084217303008421730Lincotek Medical3110 Stage Post Dr Ste 117, Bartlett, TN 38133 US2026
30100394003010039400Lincotek Medical LLC811 Northwoods Blvd, Vandalia, OH 45377 US2026and 26 more, listed in full below
30112992383011299238Lincotek Medical LLC3110 Stage Post Dr Ste 117, Bartlett, TN 38133 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

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Data as of , FDA export datePage updated Source: openFDA, public domain