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Z-Medical GmbH & Co. KG

Tuttlingen Baden-Wurttemberg, DE

Z-MEDICAL GMBH & CO. KG appears in FDA device records in Tuttlingen Baden-Wurttemberg, DE. FDA records list 2 510(k) clearances between and , no PMA records and one registered establishment. 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
1

510(k) clearance history

FDA records hold 2 510(k) clearances for Z-Medical GmbH & Co. KG between 2012 and 2015. The busiest year on record is 2012, with 1. The most recent is 2015, with 1.

Clearances by year, as a table
510(k) clearance decisions for Z-Medical GmbH & Co. KG, by decision year
YearClearances
20121
20151
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K143200MIS Z-Pedicle Screw SystemNKBSubstantially Equivalent
K121277Z-SNAP OFF SCREW, Z-DOUBLE THREAD COMPRESSION SCREW, Z-GUIDE WIRE, Z-STAPLEHWCSubstantially Equivalent

Registered establishments

FDA registered establishments for Z-Medical GmbH & Co. KG, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30091101333009110133Z-MEDICAL GMBH & CO. KGGansacker 38, Tuttlingen Baden-Wurttemberg 78532 DE2026and 4 more, listed in full below

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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What MDM checks, and what it does not

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