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

Epalinges Vaud, CH

GETSET SURGICAL S.A. appears in FDA device records in Epalinges Vaud, CH. FDA records list 2 510(k) clearances between and , no PMA records and 2 registered establishments. 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
2
PMA records
0
Recall records
0
Registered establishments
2

510(k) clearance history

FDA records hold 2 510(k) clearances for Getset Surgical S.A. between 2021 and 2025. The busiest year on record is 2021, with 1. The most recent is 2025, with 1.

Clearances by year, as a table
510(k) clearance decisions for Getset Surgical S.A., by decision year
YearClearances
20211
20251
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K250186GoLIF! Lumbar Interbody Fusion SystemMAXSubstantially Equivalent
K202505GetSet Surgical GoPLF! Posterior Lateral Fusion SystemNKBSubstantially Equivalent

Registered establishments

FDA registered establishments for Getset Surgical S.A., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30177805443017780544GETSET SURGICAL S.A.Route de la Corniche 4, Epalinges Vaud 1066 CH2026
30273862293027386229GetSet Surgical Inc.4380 Swinnea Rd Bldg C, Memphis, TN 38118 US2026No device listings on this registration

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