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

Richardson, TX, US

GRAMERCY EXTREMITY ORTHOPEDICS, LLC. appears in FDA device records in Richardson, TX. FDA records list 5 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
5
PMA records
0
Recall records
1
Registered establishments
1

510(k) clearance history

FDA records hold 5 510(k) clearances for Gramercy Extremity Orthopedics, LLC. between 2019 and 2021. The busiest year on record is 2020, with 2. The most recent is 2021, with 2.

Clearances by year, as a table
510(k) clearance decisions for Gramercy Extremity Orthopedics, LLC., by decision year
YearClearances
20191
20202
20212
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K212334GEO Extremity and Ankle Plating SystemHRSSubstantially Equivalent
K210534GEO FirstFUSE 1st MTP Joint Arthrodesis Plating SystemHRSSubstantially Equivalent
K202817GEO Bone Screw SystemHWCSubstantially Equivalent
K200108GEO 1st MTP Joint Arthrodesis Plating SystemHRSSubstantially Equivalent
K182212Geo Staple SystemJDRSubstantially Equivalent

Registered establishments

FDA registered establishments for Gramercy Extremity Orthopedics, LLC., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30124785853012478585GRAMERCY EXTREMITY ORTHOPEDICS, LLC.1239 N Glenville Dr, Richardson, TX 75081 US2026and 6 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-1395-2023GEO Instrument Kit for EPS Plate, REF: 70120001, part of the GEO FirstFUSE 1st MTP Joint Arthrodesis Plating SystemInstrument Kits for EPS plates may contain drill guides with incorrect drill depth range of 30mm - 60mm; not the correct drill depth range of 10mm - 40mm.Class IIOpen, Classified

Verification record

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