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

Tanner, AL, US

CURITEVA, INC. appears in FDA device records in Tanner, AL. FDA records list 15 510(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
15
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 15 510(k) clearances for Curiteva, Inc. between 2018 and 2026. The busiest year on record is 2018, with 4. The most recent is 2026, with 2.

Clearances by year, as a table
510(k) clearance decisions for Curiteva, Inc., by decision year
YearClearances
20184
20191
20211
20233
20243
20251
20262
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody System; Curiteva Porous PEEK Laminoplasty System; Curiteva Porous PEEK Standalone ALIF SystemODPSubstantially Equivalent
K254061Curiteva Porous PEEK Cervical Interbody Fusion SystemODPSubstantially Equivalent
K250845Curiteva Porous PEEK Standalone ALIF SystemOVDSubstantially Equivalent
K243137Curiteva Porous PEEK Laminoplasty SystemNQWSubstantially Equivalent
K233360Curiteva Thoracolumbar Plate SystemKWQSubstantially Equivalent
K233744Curiteva Porous PEEK Lumbar Interbody Fusion SystemMAXSubstantially Equivalent
K231232Curiteva Laminoplasty SystemNQWSubstantially Equivalent
K213030Curiteva Porous PEEK Cervical Interbody Fusion SystemODPSubstantially Equivalent
K223200Curiteva Navigation SystemOLOSubstantially Equivalent
K210402Curiteva Sacroiliac Joint Fusion SystemOURSubstantially Equivalent
K191810Curiteva Pedicle Screw SystemNKBSubstantially Equivalent
K181589Curiteva Lumbar Interbody Fusion SystemMAXSubstantially Equivalent
K181549Curiteva Midline Anterior Cervical Plate System (or Curiteva Anterior Cervical Plate System)KWQSubstantially Equivalent
K181562Curiteva Anterior Cervical Plate SystemKWQSubstantially Equivalent
K181261Curiteva Cervical Interbody Fusion SystemODPSubstantially Equivalent

Registered establishments

FDA registered establishments for Curiteva, Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30121311843012131184CURITEVA, INC.25127 WILL MCCOMB DR, Tanner, AL 35671 US2026and 12 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