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

Morgantown, WV, US

Omnia Medical appears in FDA device records in Morgantown, WV. FDA records list 11 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
11
PMA records
0
Recall records
2
Registered establishments
1

510(k) clearance history

FDA records hold 11 510(k) clearances for Omnia Medical between 2017 and 2025. The busiest year on record is 2020, with 3. The most recent is 2025, with 1.

Clearances by year, as a table
510(k) clearance decisions for Omnia Medical, by decision year
YearClearances
20171
20192
20203
20221
20232
20241
20251
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K242431Omnia Medical PsiF DNA™ SystemOURSubstantially Equivalent
K240623Omnia Medical TiBrid™-SA SystemOVDSubstantially Equivalent
K230424Omnia Medical Coupler-A™ Anterior Lumbar Plate System; Omnia Medical Coupler-L™ Lateral Lumbar Plate SystemKWQSubstantially Equivalent
K223321Omnia Medical Coupler-C Anterior Cervical PlateKWQSubstantially Equivalent
K212612Omnia Medical TiBrid-SCOVESubstantially Equivalent
K203207Omnia Medical TiBrid-SAOVDSubstantially Equivalent
K192096Omnia Medical Trauma ScrewsHWCSubstantially Equivalent
K190363Omnia Medical TiBrid Cervical Cage, Omnia Medical TiBrid Lateral Cage, Omnia Medical TiBrid ALIF Cage, Omnia Medical TiBrid PLIF Cage, Omnia Medical TiBrid TLIF CageMAXSubstantially Equivalent
K191778Omnia Medical VBRPLRSubstantially Equivalent
K183659Omnia Medical Rotary PLIF SystemMAXSubstantially Equivalent
K172323Omnia Medical VBRMQPSubstantially Equivalent

Registered establishments

FDA registered establishments for Omnia Medical, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30105606533010560653Omnia Medical6 Canyon Rd, MORGANTOWN, WV 26508 US2026and 9 more, listed in full below

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-2557-2025TiBrid Stand Alone Intervertebral Body Fusion Device, TiBrid SA Angled Screwdrivers, Sizes 30 degree, 45 degree, and 60 degree angles.Failure of fusion system instruments in the field.Class IIOpen, Classified
Z-2556-2025TiBrid Stand Alone Intervertebral Body Fusion Device, SA Angled Punch Awl, Sizes: 30 degree, 45 degree and 60 degree.Failure of fusion system instruments in the field.Class IIOpen, Classified

Verification record

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