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

Martillac Nouvelle-Aquitaine, FR

IMPLANET appears in FDA device records in Martillac Nouvelle-Aquitaine, FR. FDA records list 18 510(k) clearances between and , no PMA records and one registered establishment. 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
18
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 18 510(k) clearances for Implanet between 2012 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 Implanet, by decision year
YearClearances
20121
20131
20141
20153
20162
20173
20193
20231
20241
20251
20261
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K254017SWINGO-3D Lumbar Cage SystemMAXSubstantially Equivalent
K252437JAZZ Spinal SystemNKBSubstantially Equivalent
K240392JAZZ Spinal SystemNKBSubstantially Equivalent
K230026SQUALEODPSubstantially Equivalent
K192084Madison Total Knee SystemJWHSubstantially Equivalent
K191217JAZZ PFOWISubstantially Equivalent
K182771ISS-JAZZ Screw System and JAZZ CAP SPNKBSubstantially Equivalent
K171881JAZZ Passer BandOWISubstantially Equivalent
K170730JAZZ System, including JAZZ BandOWISubstantially Equivalent
K162764JAZZ FRAME SYSTEMNKBSubstantially Equivalent
K160226JAZZ CLAW System (hooks and rods) and JAZZ CLAW connectorNKBSubstantially Equivalent
K153348JAZZ LOCKOWISubstantially Equivalent
K151740JAZZ SystemOWISubstantially Equivalent
K143759JAZZ SystemOWISubstantially Equivalent
K143731IMPLANET Spine System (ISS)NKBSubstantially Equivalent
K133617JAZZ SYSTEMOWISubstantially Equivalent
K132303IMPLANET SPINE SYSTEMOSHSubstantially Equivalent
K121541JAZZ SYSTEMJDQSubstantially Equivalent

Registered establishments

FDA registered establishments for Implanet, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30076755543007675554IMPLANETTechnopole Bordeaux Montesquieu, Martillac Nouvelle-Aquitaine 33650 FR2026and 4 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

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