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

Memphis, TN, US

CROSSROADS EXTREMITY SYSTEMS LLC appears in FDA device records in Memphis, TN. FDA records list 16 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
16
PMA records
0
Recall records
2
Registered establishments
1

510(k) clearance history

FDA records hold 16 510(k) clearances for Crossroads Extremity Systems LLC between 2015 and 2026. The busiest year on record is 2015, with 3. The most recent is 2026, with 1.

Clearances by year, as a table
510(k) clearance decisions for Crossroads Extremity Systems LLC, by decision year
YearClearances
20153
20162
20183
20192
20201
20221
20232
20241
20261
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K253178TRILEAP Plating SystemHRSSubstantially Equivalent
K241050CrossRoads Modular Tray SystemKCTSubstantially Equivalent
K230591TriLEAP Plating SystemHRSSubstantially Equivalent
K223342MotoBAND™ CP Implant System: DynaBunion™ 4D Minimal-incision Bunion System, DynaMET™ Lesser TMT Fusion SystemHRSSubstantially Equivalent
K220797FootHold SystemMBISubstantially Equivalent
K202268CrossRoads Tray SystemKCTSubstantially Equivalent
K190658MIS Bunion Plating SystemHRSSubstantially Equivalent
K181872MIS Bunion SystemHRSSubstantially Equivalent
K181866MotoCLIP/HiMAX Step Staple Implant SystemJDRSubstantially Equivalent
K181410MotoCLIP/HiMAX Implant SystemJDRSubstantially Equivalent
K173710MotoBAND CP Implant SystemHWCSubstantially Equivalent
K160118STROPP (Single Tunnel Repair of Plantar Plate)MBISubstantially Equivalent
K160300MotoBand(TM) CP Implant SystemHRSSubstantially Equivalent
K152306MotoBand¿ CP Implant SystemHRSSubstantially Equivalent
K152072CrossRoads Screw SystemHWCSubstantially Equivalent
K151270CrossTIE Intraosseous Fixation SystemHWCSubstantially Equivalent

Registered establishments

FDA registered establishments for Crossroads Extremity Systems LLC, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30205842463020584246CROSSROADS EXTREMITY SYSTEMS LLC6423 Shelby View Dr, Memphis, TN 38134 US2026and 15 more, listed in full below

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

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-0212-2020MotoBand CP, Poly-axial Locking Screw, 3.0mm x 28mmPotentially includes a 3.0mm x 30mm screw instead of 3.0mm x 28mm screw.Class IITerminated
Z-1487-2017MotoCLIP(TM) Super Elastic Fusion System, Size 18mm x 14mm x 14mm, REF 1442-1814, Rx Only, STERILE R.Seven 18mm x 18mm x 18 mm implants had been placed in kits, packed and labeled as 18mm x 14mm x 14mm.Class IITerminated

Verification record

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