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

Pompano Beach, FL, US

Miami Device Solutions, LLC appears in FDA device records in Pompano Beach, FL. FDA records list 7 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show one recall for this company.

FDA records held for this company

510(k) clearances
7
PMA records
0
Recall records
1
Registered establishments
0

510(k) clearance history

FDA records hold 7 510(k) clearances for Miami Device Solutions, LLC between 2015 and 2018. The busiest year on record is 2016, with 3. The most recent is 2018, with 1.

Clearances by year, as a table
510(k) clearance decisions for Miami Device Solutions, LLC, by decision year
YearClearances
20151
20163
20172
20181
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K182810Distal Radius Plating SystemHRSSubstantially Equivalent
K172786MDS Plating SystemHRSSubstantially Equivalent
K162898Olecranon Plating SystemHRSSubstantially Equivalent
K162635Distal Radius Plating SystemHRSSubstantially Equivalent
K161292Distal Radius Plating SystemHRSSubstantially Equivalent
K161058Cannulated ScrewHWCSubstantially Equivalent
K141493PROXIMAL HUMERUS PLATING SYSTEMHRSSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-0603-2020Proximal Humerus Plate, 8 holes, Right, REF MDS130108R - Product Usage: The Proximal Humerus Plating System consists of plates, screws, and locking caps intended to provide internal fixation of fractures of the proximal humerus. The polyaxial screws have a range of motion of +/- 20. The screws can be simply lagged or locked to the plate with the addition of a locking cap. The plates are side specific implants.Right Proximal Humerus Plates. Product component parts MDS130108R, may be improperly identified as left.Class IITerminated

Verification record

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