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

Carrollton, TX, US

SOLCO BIOMEDICAL CORP. appears in FDA device records in Carrollton, TX. FDA records list 17 510(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
17
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 17 510(k) clearances for Solco Biomedical Corp. between 2005 and 2024. The busiest year on record is 2019, with 4. The most recent is 2024, with 1.

Clearances by year, as a table
510(k) clearance decisions for Solco Biomedical Corp., by decision year
YearClearances
20053
20061
20082
20101
20112
20121
20171
20194
20221
20241
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K2316554CIS® Chiron Spinal Fixation SystemNKBSubstantially Equivalent
K2032334CIS Chiron Spinal Fixation SystemNKBSubstantially Equivalent
K1920444CIS Marlin PEEK ACIF CageODPSubstantially Equivalent
K1905634CIS PEEK PLIF Cage, 4CIS Pebble Beach PEEK PLIF Cage, 4CIS Torrey Pines PEEK TLIF Cage, 4CIS Dunes PEEK DLIF Cage, 4CIS Augusta PEEK ALIF CageMAXSubstantially Equivalent
K1904714CIS® Chiron Spinal Fixation SystemNKBSubstantially Equivalent
K1824894CIS® Pinehurst Anterior Cervical Plate systemKWQSubstantially Equivalent
K1624024CIS® Marlin ACIF Cage SystemODPSubstantially Equivalent
K1216154CIS VANE SPINE SYSTEMMNISubstantially Equivalent
K1024584CIS SOLAR SPINE SYSTEM AND 4CIS APOLLON SPINE SYSTEMMNHSubstantially Equivalent
K1018184CIS VANE SPINE SYSTEMMNHSubstantially Equivalent
K0921624CIS PEEK, PLIF AND TLIF CAGE SYSTEMMAXSubstantially Equivalent
K081145MODIFICATION TO 4CIS VANE SPINE SYSTEMMNISubstantially Equivalent
K0824534CIS SOLAR AND APOLLON SPINE SYSTEMSMNHSubstantially Equivalent
K0607024CIS VANE SPINE SYSTEMMNHSubstantially Equivalent
K051155SOLCO 4CIS GENERAL PLATE SYSTEMHRSSubstantially Equivalent
K0504714CIS SOLAR SPINE SYSTEM AND 4CIS APOLLON SPINE SYSTEMMNHSubstantially Equivalent
K043578THE 4CIS SPINAL SYSTEM AND 4CIS LOW BACK SYSTEMMNHSubstantially Equivalent

Registered establishments

FDA registered establishments for Solco Biomedical Corp., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30105096333010509633SOLCO BIOMEDICAL CORP.4100 Midway Rd Ste 1130, Carrollton, TX 75007 US2026and 18 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

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

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What MDM checks, and what it does not

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