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

Calderara di Reno Bologna, IT

CITIEFFE INC. appears in FDA device records in Calderara di Reno Bologna, IT. FDA records list 11 510(k) clearances between and , no PMA records and 2 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
11
PMA records
0
Recall records
0
Registered establishments
2

510(k) clearance history

FDA records hold 11 510(k) clearances for Citieffe Inc. between 2012 and 2025. The busiest year on record is 2012, with 3. The most recent is 2025, with 1.

Clearances by year, as a table
510(k) clearance decisions for Citieffe Inc., by decision year
YearClearances
20123
20131
20141
20151
20171
20181
20192
20251
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K250197Estremo Fibular NailHSBSubstantially Equivalent
K183666EBA One Nailing SystemHSBSubstantially Equivalent
K181540Estremo Citieffe Nailing SystemHSBSubstantially Equivalent
K180150PL8 Wrist Reconstruction PlateHRSSubstantially Equivalent
K163323Dolphix® External Fixation System MR ConditionalKTTSubstantially Equivalent
K150661ST.A.R. 90 F4 External Fixation Screws With HydroxyapatiteJDWSubstantially Equivalent
K132363DOLPHIX EXTERNAL FIXATION SYSTEMKTTSubstantially Equivalent
K131005EBA2 FEMORAL NAILING SYSTEMHSBSubstantially Equivalent
K113388CITIEFFE-TITANIUM CANNULATED SCREWHWCSubstantially Equivalent
K113384EXTERNAL FIXATOR ST.A R 90 F4KTTSubstantially Equivalent
K113387CITIEFFE TITANIUM NAILING SYSTEMHSBSubstantially Equivalent

Registered establishments

FDA registered establishments for Citieffe Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30095306653009530665CITIEFFE INC.3692 Grand Avenue #473, Miami, FL 33133 US2026No device listings on this registration
30032493803003249380CITIEFFE SRLVia Armaroli 21, Calderara di Reno Bologna 40012 IT2026and 3 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