510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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KLS-Martin L.P.

Jacksonville, FL, US

KLS-Martin L.P. appears in FDA device records in Jacksonville, FL. FDA records list 78 510(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
78
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

Showing 50 of 78

FDA records hold 78 510(k) clearances for KLS-Martin L.P. between 1994 and 2026. The busiest year on record is 2006, with 7. The most recent is 2026, with 2.

Clearances by year, as a table
510(k) clearance decisions for KLS-Martin L.P., by decision year
YearClearances
19943
19973
19981
19993
20003
20013
20021
20032
20046
20052
20067
20073
20081
20091
20122
20131
20142
20152
20164
20173
20183
20193
20202
20224
20234
20243
20254
20262
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K254162KLS Martin Ixos SystemHRSSubstantially Equivalent
K253660KLS Martin Pure Pectus SystemHRSSubstantially Equivalent
K250988KLS Martin Pure Pectus SystemHRSSubstantially Equivalent
K250865KLS Martin IPS Forearm SystemHRSSubstantially Equivalent
K252573KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis System (1.5MM); K971297: KLS Martin Centre-Drive Drill-Free Screw; K060177: KLS Martin Rigid Fixation - Sterile; K062570: Individual Patient Solutions - Ti (IPS-Ti); K072707: Individual Patient Solutions - PEEK (IPS-PEEK) ; K151382: Individual Patient Solutions - (IPS-PEEK) - STERILEGXNSubstantially Equivalent
K250620KLS Martin Ixos SystemHRSSubstantially Equivalent
K233721KLS Martin Drill-Free MMF ScrewDZLSubstantially Equivalent
K241314KLS Martin Oral-Max Implants MR Conditional (bundled)JEYSubstantially Equivalent
K241018KLS Martin Orthopedic Implants - MR ConditionalHRSSubstantially Equivalent
K230211CranioXpandPBJSubstantially Equivalent
K222624KLS Martin LINOS Wrist SystemHRSSubstantially Equivalent
K222397KLS Martin Level One Rib Fixation SystemHRSSubstantially Equivalent
K221938KLS Martin Pure Pectus SystemHRSSubstantially Equivalent
K220050KLS Martin IPS DistractionMQNSubstantially Equivalent
K210731KLS Martin Individual Patient SolutionsJEYSubstantially Equivalent
K210228KLS Martin IPS PreprostheticELESubstantially Equivalent
K210741KLS Martin Neuro RongeursHAESubstantially Equivalent
K201052KLS Martin Individual Patient Solutions (IPS) Planning SystemPPTSubstantially Equivalent
K192979KLS Martin Individual Patient Solutions (IPS) Planning SystemPBFSubstantially Equivalent
K191028KLS Martin Individual Patient SolutionsJEYSubstantially Equivalent
K182889KLS Martin Individual Patient Solutions (IPS) Planning SystemPPTSubstantially Equivalent
K182789KLS Martin Individual Patient Solutions (IPS) Planning SystemDZJSubstantially Equivalent
K181241KLS Martin Individual Patient Solutions (IPS) Planning SystemDZJSubstantially Equivalent
K180962KLS Martin Individual Patient SolutionsJEYSubstantially Equivalent
K173320KLS Martin L1 MMF SystemJEYSubstantially Equivalent
K163579KLS Martin Individual Patient SolutionsJEYSubstantially Equivalent
K163315Internal Distraction - SterilePBJSubstantially Equivalent
K170124Level One Hand Plating SystemHRSSubstantially Equivalent
K161259KLS Martin Cannulated Headless ScrewsHWCSubstantially Equivalent
K161470Internal Distraction - SterileMQNSubstantially Equivalent
K153482KLS Martin Thoracic Plating SystemHRSSubstantially Equivalent
K151983KLS Martin LSS Plating SystemJDQSubstantially Equivalent
K151382Patient Contoured Implant-PEEK (PCI-PEEK)GXNSubstantially Equivalent
K150771RxG Distraction SystemPBJSubstantially Equivalent
K141489LINOS MOH HAND PLATING SYSTEMHRSSubstantially Equivalent
K133304RXG DISTRACTION SYSTEMJEYSubstantially Equivalent
K121606RESORB-X GGWOSubstantially Equivalent
K122860KLS MARTIN RECON TALONHRSSubstantially Equivalent
K112064RESORB X-GJEYSubstantially Equivalent
K083432DRILL FREE MMF SCREWDZLSubstantially Equivalent
K080862SONICWELD RX (RESORB-X)JEYSubstantially Equivalent
K072764KLS MARTIN XTERNAL FIXATORMQNSubstantially Equivalent
K072707PATIENT CONTOURED MESH-PEEK (PCM-P)GXNSubstantially Equivalent
K070169KLS MARTIN QUICK DISC, STERNAL TALON AND STERNAL PLATING - STERILEHRSSubstantially Equivalent
K062857KLS MARTIN QUICK DISCGXNSubstantially Equivalent
K062570PATIENT CONTOURED MESH (PCM)GXNSubstantially Equivalent
K061507SONICWELD RX ENDOBROW FIXATIONJEYSubstantially Equivalent
K051165KLS MARTIN STERNAL TALONHRSSubstantially Equivalent
K061271ERCH ARCH BAR, MODEL 38-690-00DYXSubstantially Equivalent
K060177KLS MARTIN RIGID FIXATION - STERILEJEYSubstantially Equivalent

Registered establishments

FDA registered establishments for KLS-Martin L.P., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
10579461000525271KLS-Martin L.P.11201 Saint Johns Industrial Pkwy S, Jacksonville, FL 32246 US2026and 147 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.

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