510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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G-5 Florida LLC

Jax, FL, US

G-5 FLORIDA LLC appears in FDA device records in Jax, FL. FDA records list 2 510(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
2
PMA records
0
Recall records
1
Registered establishments
1

FDA records under these names

1 name

FDA records resolved to G-5 Florida LLC carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

  • Anjon Holdings, LLC510(k), enforcement report, recall

510(k) clearance history

FDA records hold 2 510(k) clearances for G-5 Florida LLC between 2018 and 2020. The busiest year on record is 2018, with 1. The most recent is 2020, with 1.

Clearances by year, as a table
510(k) clearance decisions for G-5 Florida LLC, by decision year
YearClearances
20181
20201
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K193256Anjon Bremer Halo SystemJECSubstantially Equivalent
K171863Anjon Bremer Halo SystemJECSubstantially Equivalent

Registered establishments

FDA registered establishments for G-5 Florida LLC, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
10663683003346235G-5 FLORIDA LLC4801 Dawin Rd, JAX, FL 32207 US2026

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-2778-2020Anjon Bremer Molded Crown. bone fixation fastener for spinal use. REF number 100048 - Product Usage: Smooth or threaded metallic bone fixation fastener. Provides cervical spine immobilization and therapeutic traction for treatment of patients with cervical trauma or other neck conditions.High rate of galling of one threaded component.Class IITerminated

Verification record

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