FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Orthopedic ×
17,850 results
12265–12288 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Aug 23, 2002
UNI KNEE
K022437 · HRY
Encore Medical, L.P.
Orthopedic · 29d
Cleared Aug 23, 2002
ENDIUS FLEXTIP BLADE
K022578 · HRX
Endius, Inc.
Orthopedic · 18d
Cleared Aug 22, 2002
S2 FEMORAL NAIL
K022461 · HSB
Howmedica Osteonics
Orthopedic · 27d
Cleared Aug 21, 2002
BLACKSTONE SPINAL FIXATION SYSTEM STAPLE & WASHER
K022605 · KWQ
Blackstone Medical, Inc.
Orthopedic · 15d
Cleared Aug 19, 2002
TOTAL KNEE FEMORAL COMPONENT
K022010 · JWH
Smith & Nephew, Inc.
Orthopedic · 61d
Cleared Aug 16, 2002
CEMENT RESTRICTOR, SMALL AND LARGE
K021765 · JDK
Exactech, Inc.
Orthopedic · 79d
Cleared Aug 16, 2002
HA MODULAR REACH PROXIMAL POROUS AND HA MODULAR REACH COLLARED PROXIMAL...
K022463 · LPH
Biomet Orthopedics, Inc.
Orthopedic · 21d
Cleared Aug 15, 2002
FORTITUDE CEMENT RESTRICTOR
K021719 · JDK
Spinal Concepts, Inc.
Orthopedic · 84d
Cleared Aug 15, 2002
ANTERIOR STABILIZED TIBIAL BEARINGS
K022586 · JWH
Biomet Orthopedics, Inc.
Orthopedic · 10d
Cleared Aug 13, 2002
MODIFICATION TO ISOLA SPINAL SYSTEM
K022285 · MNI
Depuyacromed
Orthopedic · 29d
Cleared Aug 12, 2002
HALLU PLATES
K021626 · HRS
New Deal, S.A.
Orthopedic · 87d
Cleared Aug 12, 2002
UKNEE TOTAL KNEE SYSTEM
K021657 · JWH
United Orthopedic Corp.
Orthopedic · 84d
Cleared Aug 12, 2002
MAGLY 6.5MM CANNULATED SCREWS
K021662 · HWC
Magly Orthopedics, LLC
Orthopedic · 84d
Cleared Aug 12, 2002
EBI DYNAFIX VS OSTEOTOMY SYSTEM
K021749 · NDF
Ebi, L.P.
Orthopedic · 76d
Cleared Aug 12, 2002
CADENCE CEMENT RESTRICTOR
K022218 · JDK
Spinal Concepts, Inc.
Orthopedic · 34d
Cleared Aug 12, 2002
EBI XFIX DFS SYSTEM
K022319 · KTT
Ebi, L.P.
Orthopedic · 26d
Cleared Aug 12, 2002
EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM
K022419 · KWQ
Ebi, L.P.
Orthopedic · 19d
Cleared Aug 09, 2002
SYNTHES 2.4 MM CANNULATED COMPRESSION SCREW
K021556 · HWC
Synthes (Usa)
Orthopedic · 88d
Cleared Aug 09, 2002
NATURAL-KNEE II SYSTEM COCR TIBIAL BASEPLATE
K021578 · JWH
Sulzer Orthopedics, Inc.
Orthopedic · 87d
Cleared Aug 09, 2002
MAGLY 4.0 AND 5.5 MM LOCKING SYSTEM
K021579 · HWC
Magly Orthopedics, LLC
Orthopedic · 87d
Cleared Aug 06, 2002
SINTEA BIOTECH TRAUMAFIX SYSTEM, MODEL TFX.00.00.X
K022065 · JEC
Sintea Biotech, Inc.
Orthopedic · 42d
Cleared Aug 06, 2002
BLACKSTONE SPINAL FIXATION SYSTEM SPACER
K022399 · KWQ
Blackstone Medical, Inc.
Orthopedic · 14d
Cleared Aug 01, 2002
PLUS PIVOT LINK UNIVERSAL SYSTEM
K021507 · KWP
Spine Vision, Inc.
Orthopedic · 84d
Cleared Aug 01, 2002
UNI-T UNI-THREAD SPINAL SYSTEM
K021510 · MNI
Spine Vision, Inc.
Orthopedic · 84d