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
15721–15744 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Feb 09, 1993
FOUNDATION KNEE SYSTEM
K923277 · JWH
Encore Orthopedics, Inc.
Orthopedic · 218d
Cleared Feb 09, 1993
NUCLEOTOME 3.5 MM AUTOMATED PERCUTANEOUS LUMBAR
K923525 · HRX
Surgical Dynamics, Inc.
Orthopedic · 208d
Cleared Feb 09, 1993
ETEX HIP REPLACEMENT SYSTEM
K925895 · JDI
Etex Co.
Orthopedic · 85d
Cleared Feb 08, 1993
RESORABPLUG
K920118 · LZN
Sofamor Danek Mfg., Inc.
Orthopedic · 392d
Cleared Feb 08, 1993
ARTHREX KNEE ARTHROSCOPIC SURGERY ACCESSORIES
K922890 · HRX
Arthrex, Inc.
Orthopedic · 238d
Cleared Feb 08, 1993
ARTHREX ATRAUMATIC MINI-GRASPER
K925455 · HRX
Arthrex, Inc.
Orthopedic · 115d
Cleared Feb 05, 1993
TECHMEDICA MUELLER TYPE POLYETHYLENE ACETBUL CUP
K925181 · JDL
Techmedica, Inc.
Orthopedic · 114d
Cleared Jan 21, 1993
PARAGON POSTERIOR SPINAL SYSTEM
K920546 · KWP
Sofamor Danek Mfg., Inc.
Orthopedic · 350d
Cleared Jan 21, 1993
SYNTHES TI-6AI-7NB UNREAMED FEMORAL NAIL
K923580 · HSB
Synthes (Usa)
Orthopedic · 185d
Cleared Jan 21, 1993
SYNTHES TITANIUM UNREAMED FEMORAL NAIL
K923597 · HSB
Synthes (Usa)
Orthopedic · 185d
Cleared Jan 07, 1993
DEPUY HIP PROSTHESIS
K914078 · JDI
Depuy, Inc.
Orthopedic · 484d
Cleared Jan 07, 1993
LSF ANATOMIC CEMENTED HIP
K922645 · JDI
Osteo Technology, Inc.
Orthopedic · 218d
Cleared Dec 31, 1992
ISOLA SPINE SYSTEM: PLATE-ROD COMBINATION
K920392 · KWP
Acromed Corp.
Orthopedic · 336d
Cleared Dec 31, 1992
ISOLA(R) TRANSVERSE ROD DUAL CONNECTOR
K921090 · KWP
Acromed Corp.
Orthopedic · 300d
Cleared Dec 29, 1992
ACUFEX INTRA ARTICULAR MEASURING DEVICE
K925335 · HTJ
Acufex Microsurgical, Inc.
Orthopedic · 68d
Cleared Dec 24, 1992
PERFECTA TOTAL HIP SYSTEM, HA COATED
K915190 · MEH
Orthomet, Inc.
Orthopedic · 398d
Cleared Dec 24, 1992
ACUFEX CANNULATED BONE TUNNEL PLUGS
K925437 · HRX
Cufex Microsurgical, Inc.
Orthopedic · 57d
Cleared Dec 23, 1992
LEAPLAZA FRAME
K922238 · KWP
Spintech, Inc.
Orthopedic · 224d
Cleared Dec 17, 1992
ALVINE TOTAL ANKLE
K920802 · HSN
Depuy, Inc.
Orthopedic · 300d
Cleared Dec 17, 1992
STERILE DYNA LOK ANTERIOR PLATING SYSTEM
K923446 · KWQ
Sofamor Danek Mfg., Inc.
Orthopedic · 156d
Cleared Dec 17, 1992
RECONSTRUCTION PLATE SYSTEM
K924085 · HRS
Sofamor Danek Mfg., Inc.
Orthopedic · 126d
Cleared Dec 10, 1992
NEER TYPE SHOULDER PROSTHESIS SYSTEM
K922865 · KWT
Osteo Technology, Inc.
Orthopedic · 189d
Cleared Dec 07, 1992
ORTHOMET PERFECTA TOTAL HIP SYSTEM
K923583 · LZO
Orthomet, Inc.
Orthopedic · 140d
Cleared Nov 25, 1992
MORREY ELBOW FIXATOR
K910993 · KTT
Howmedica Corp.
Orthopedic · 629d