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

West Chester, PA, US

ALTUS PARTNERS appears in FDA device records in West Chester, PA. 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 Altus Partners between 2013 and 2025. The busiest year on record is 2017, with 6. The most recent is 2025, with 1.

Clearances by year, as a table
510(k) clearance decisions for Altus Partners, by decision year
YearClearances
20131
20151
20176
20182
20192
20201
20212
20222
20251
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K243419Altus Spine Navigation SystemOLOSubstantially Equivalent
K211027Altus Spine Pedicle Screw SystemNKBSubstantially Equivalent
K211837Altus Spine Interbody Standalone Fusion SystemOVDSubstantially Equivalent
K210887Altus Spine Sochi OCT Spinal SystemNKGSubstantially Equivalent
K200922Altus Spine HA Pedicle Screw SystemNKBSubstantially Equivalent
K200322Altus Spine Pedicle Screw SystemNKBSubstantially Equivalent
K183084Fuji Cervical Plate SystemKWQSubstantially Equivalent
K182406Altus Spine Interbody Fusion SystemMAXSubstantially Equivalent
K181339Altus Spine Pedicle Screw SystemNKBSubstantially Equivalent
K181281Altus Spine Pedicle Screw SystemNKBSubstantially Equivalent
K170553Altus Spine Interbody Fusion SystemMAXSubstantially Equivalent
K172253Altus Spine Cervical Interbody Fusion SystemODPSubstantially Equivalent
K171329Altus Spine Titanium Interbody Fusion SystemMAXSubstantially Equivalent
K170512Altus Spine Titanium Interbody Fusion SystemMAXSubstantially Equivalent
K163061Altus Spine Cervical Plate SystemKWQSubstantially Equivalent
K160976Altus Spine Interbody Fusion SystemMAXSubstantially Equivalent
K151648Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle Screw System, Valencia MIS Pedicle Screw SystemNKBSubstantially Equivalent
K132280ALTUS SPINE PEDICLE SCREW SYSTEMMNISubstantially Equivalent

Registered establishments

FDA registered establishments for Altus Partners, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30090491613009049161ALTUS PARTNERS1340 ENTERPRISE DR, WEST CHESTER, PA 19380 US2026

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