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

Sparks, NV, US

NEO MEDICAL INC. appears in FDA device records in Sparks, NV. FDA records list 6 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
6
PMA records
0
Recall records
1
Registered establishments
2

510(k) clearance history

FDA records hold 6 510(k) clearances for Neo Medical, Inc. between 2017 and 2024. The busiest year on record is 2019, with 2. The most recent is 2024, with 1.

Clearances by year, as a table
510(k) clearance decisions for Neo Medical, Inc., by decision year
YearClearances
20171
20192
20211
20221
20241
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K243693NEO Pedicle Screw System™NKBSubstantially Equivalent
K222256BonOs® Inject Bone Cement; NEO Pedicle Screw System™PMLSubstantially Equivalent
K212489BonOs Inject Bone Cement; NEO Pedicle Screw SystemPMLSubstantially Equivalent
K191796Neo Cage SystemMAXSubstantially Equivalent
K181048Neo Cage System TMMAXSubstantially Equivalent
K171582NEO Pedicle Screw System™NKBSubstantially Equivalent

Registered establishments

FDA registered establishments for Neo Medical, Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30072079063007207906NEO MEDICAL INC.249 Freeport Blvd, Sparks, NV 89431 US2026and 1 more, listed in full below
30135464623013546462NEO MEDICAL S.A.Route de Lausanne 157A, Villette (Lavaux) Vaud 1096 CH2026and 5 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-2223-2011V-CATH Insertion Kits, Sterile; Product Code Number: 301-00; Manufactured by Centurion Medical Products for Neo Medical; 42514 Albrae Street, Fremont, CA 94538Firm received recall notice from their contract manufacturer due to visible particulates in Bacteriostatic Sodium Chloride Injection, USP 0.9%, 30 mL vials that are included in insertion kits.Terminated

Verification record

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