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

SCHOENKIRCHEN Schleswig-Holstein, DE

STRYKER TRAUMA GMBH appears in FDA device records in SCHOENKIRCHEN Schleswig-Holstein, DE. FDA records list 32 510(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
32
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 32 510(k) clearances for Stryker Trauma GmbH between 2013 and 2020. The busiest year on record is 2013, with 11. The most recent is 2020, with 2.

Clearances by year, as a table
510(k) clearance decisions for Stryker Trauma GmbH, by decision year
YearClearances
201311
201411
20153
20172
20182
20191
20202
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K200869Gamma3 SystemHSBSubstantially Equivalent
K193308T2 Alpha Tibia Nailing System, IMN Screws SystemHSBSubstantially Equivalent
K191271T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System, IMN Screws System, IMN Instruments SystemHSBSubstantially Equivalent
K180436T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments SystemHSBSubstantially Equivalent
K172774T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments SystemHSBSubstantially Equivalent
K172210ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA)KWSSubstantially Equivalent
K170418Stryker SonicPin SystemHTYSubstantially Equivalent
K153154Asnis JFX SystemHWCSubstantially Equivalent
K151178VariAx 2 Wrist Fusion SystemHRSSubstantially Equivalent
K143063Stryker SonicPin System, Stryker SonicAnchor SystemHTYSubstantially Equivalent
K143138AxSOS 3 Ti Locking Plate SystemHRSSubstantially Equivalent
K140961HOFFMANN LRF (LIMB RECONSTRUCTION FRAME) SYSTEMKTTSubstantially Equivalent
K141992VARIAX 2 SYSTEMHRSSubstantially Equivalent
K141677VARIAX ELBOW PLATING SYSTEMHRSSubstantially Equivalent
K141204VARIAX 2 ONE THIRD TUBULAR PLATING SYSTEMHRSSubstantially Equivalent
K141121AXSOS 3 TI LOCKING PLATE SYSTEMHRSSubstantially Equivalent
K140565VARIAX 2 COMPRESSION PLATING SYSTEMHRSSubstantially Equivalent
K140769VARIAX 2 SYSTEMHRSSubstantially Equivalent
K140376VARIAX 2 SYSTEMHRSSubstantially Equivalent
K140259VARIAX CLAVICLE HOOK PLATEHRSSubstantially Equivalent
K133451FIXOS SCREW SYSTEMHWCSubstantially Equivalent
K133440AXSOS 3 TI LOCKING PLATE SYSTEM LINE EXTENSIONHWCSubstantially Equivalent
K132502VARIAX 2 SYSTEMHRSSubstantially Equivalent
K131365T2 TIBIAL NAILING SYSTEMHSBSubstantially Equivalent
K130907HOFFMANN LRF (LIMB RECONSTRUCTION FRAME) SYSTEMKTTSubstantially Equivalent
K131132PELVIS II IMPLANT SYSTEMHRSSubstantially Equivalent
K130334HOFFMANN LRF (LIMB RECONSTRUCTION FRAME SYSTEM)KTTSubstantially Equivalent
K123964AXSOS 3 TI LOCKING PLATE SYSTEMHRSSubstantially Equivalent
K130009VARIAX 2 COMPRESSION PLATING SYSTEMHRSSubstantially Equivalent
K123403AXSOS PROXIMAL LATERAL TIBIA LONG PLATESHRSSubstantially Equivalent
K130116SUPERIOR LATERAL VARIAX CLAVICLE PLATEHRSSubstantially Equivalent
K123401GAMMA3 AND T2 RECON TARGETING DEVICESHSBSubstantially Equivalent

Registered establishments

FDA registered establishments for Stryker Trauma GmbH, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
96106223002807231STRYKER TRAUMA GMBHPROF. KUENTSCHER STR. 1-5, SCHOENKIRCHEN Schleswig-Holstein D-24232 DE2026and 6 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