510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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SI-Bone, Inc.

Santa Clara, CA, US

SI-BONE, INC. appears in FDA device records in Santa Clara, CA. FDA records list 32 510(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
32
PMA records
0
Recall records
0
Registered establishments
2

510(k) clearance history

FDA records hold 32 510(k) clearances for SI-Bone, Inc. between 2008 and 2026. The busiest year on record is 2022, with 4. The most recent is 2026, with 1.

Clearances by year, as a table
510(k) clearance decisions for SI-Bone, Inc., by decision year
YearClearances
20081
20091
20111
20121
20132
20141
20153
20163
20172
20181
20191
20202
20211
20224
20231
20244
20252
20261
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K253488iFuse INTRA Ti™ Implant SystemOURSubstantially Equivalent
K253094iFuse Bedrock Granite Implant SystemOURSubstantially Equivalent
K251780iGPS Navigation InstrumentsOLOSubstantially Equivalent
K241504iFuse TORQ TNT™ Implant SystemOURSubstantially Equivalent
K241574iFuse TORQ® Implant SystemOURSubstantially Equivalent
K232800Navigation Tracking InstrumentsOLOSubstantially Equivalent
K233508iFuse Bedrock Granite® Implant SystemOURSubstantially Equivalent
K231689iFuse TORQ® Implant SystemOURSubstantially Equivalent
K222774iFuse Bedrock Granite® Implant SystemOURSubstantially Equivalent
K222605iFuse TORQ® Implant SystemOURSubstantially Equivalent
K213667iFuse-TORQ® Implant SystemOURSubstantially Equivalent
K220195iFuse Bedrock Granite™ Implant SystemOURSubstantially Equivalent
K203247iFuse-TORQ™ Implant SystemOURSubstantially Equivalent
K203110iFuse Implant System - iFuse NavigationOLOSubstantially Equivalent
K193524SI-BONE iFuse Implant System®OURSubstantially Equivalent
K190230iFuse Implant System®OURSubstantially Equivalent
K182983iFuse Implant System®OURSubstantially Equivalent
K172268iFuse Implant System- iFuse NavigationOLOSubstantially Equivalent
K162733iFuse Implant System® - iFuse-3D implantOURSubstantially Equivalent
K161893Neuromonitoring KitPDQSubstantially Equivalent
K160652iFUSE Implant SystemOURSubstantially Equivalent
K152681iFuse Implant System(R)OURSubstantially Equivalent
K151718iFuse Implant SystemOURSubstantially Equivalent
K150875iFuse Implant SystemOURSubstantially Equivalent
K150714SI-BONE iFuse Implant SystemOURSubstantially Equivalent
K141049IFUSE IMPLANT SYSTEMOURSubstantially Equivalent
K131405IFUSE IMPLANT SYSTEMOURSubstantially Equivalent
K123850IFUSE IMPLANT SYSTEMOURSubstantially Equivalent
K122074IFUSE IMPLANT SYSTEMOURSubstantially Equivalent
K110838IFUSE IMPLANT SYSTEMOURSubstantially Equivalent
K092375MODIFICATION TO SI JOINT FUSION SYSTEMOURSubstantially Equivalent
K080398SI JOINT FUSION SYSTEMOURSubstantially Equivalent

Registered establishments

FDA registered establishments for SI-Bone, Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30077002863007700286SI-BONE, INC.471 El Camino Real, Suite 101, Santa Clara, CA 95050 US2026
30219480573021948057SI-BONE, INC.2380 Owen St., Santa Clara, CA 95054 US2026and 1 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

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

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