510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN

Degen Medical

Florence, SC, US

DEGEN MEDICAL appears in FDA device records in Florence, SC. FDA records list 18 510(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
18
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 18 510(k) clearances for Degen Medical between 2015 and 2025. The busiest year on record is 2015, with 3. The most recent is 2025, with 3.

Clearances by year, as a table
510(k) clearance decisions for Degen Medical, by decision year
YearClearances
20153
20161
20181
20191
20201
20212
20222
20232
20242
20253
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K251829DeGen Medical Patient Specific Implant (PSI) SystemOVDSubstantially Equivalent
K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemODPSubstantially Equivalent
K250667DeGen Medical Patient Specific Implant (PSI) SystemMAXSubstantially Equivalent
K241077DeGen Medical Patient Specific Implant (PSI) SystemOVDSubstantially Equivalent
K240326Solar™ Lumbar Interbody Fusion SystemMAXSubstantially Equivalent
K231199Solar Lumbar Interbody Fusion SystemMAXSubstantially Equivalent
K223418DeGen Impulse AM™ SystemMAXSubstantially Equivalent
K213918DeGen Navigated InstrumentationOLOSubstantially Equivalent
K213901Cyclops™ Anterior Cervical Plate SystemKWQSubstantially Equivalent
K210090Impulse AM Interbody Fusion SystemMAXSubstantially Equivalent
K203816DeGen Navigated InstrumentationOLOSubstantially Equivalent
K201287Impulse Interbody Fusion SystemMAXSubstantially Equivalent
K191786Cyclops™ Anterior Cervical Plate SystemKWQSubstantially Equivalent
K173814DeGen Medical E3 MIS Pedicle Screw SystemNKBSubstantially Equivalent
K160926F1 MPS Modular Pedicle Screw SystemNKBSubstantially Equivalent
K151496Latitude-C Cervical Interbody Spacer SystemODPSubstantially Equivalent
K150759Hyper-C Anterior Cervical Plate SystemKWQSubstantially Equivalent
K142531F1-Modular Pedicle Screw SystemNKBSubstantially Equivalent

Registered establishments

FDA registered establishments for Degen Medical, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30106633723010663372DEGEN MEDICAL1321C N Cashua Dr, Florence, SC 29501 US2026and 4 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.

Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.

What MDM checks, and what it does not

MDM coverage

MDM coverage of this company lists here, newest first. Submit news.

Is this your company?

This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.

Claiming lets Degen Medical edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.

Claim this page

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