FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Orthopedic ×
17,985 results
13345–13368 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Mar 10, 2000
MAGELLAN HUMERAL INTRAMEDULLARY NAIL
K992856 · HSB
Orthomatrix, Inc.
Orthopedic · 199d
Cleared Mar 10, 2000
INTER-OP DURASUL ACETABULAR INSERTS/COCR FEMORAL HEADS
K993259 · LPH
Sulzer Orthopedics, Inc.
Orthopedic · 163d
Cleared Mar 10, 2000
ZMR HIP SYSTEM-POROUS REVISION
K994286 · LPH
Zimmer, Inc.
Orthopedic · 81d
Cleared Mar 10, 2000
NONLINEAR TAPER LAG SCREW
K994382 · HWC
Theken Surgical
Orthopedic · 73d
Cleared Mar 10, 2000
AEQUALIS SHOULDER FRACTURE SYSTEM
K994392 · KWS
Tornier
Orthopedic · 73d
Cleared Mar 07, 2000
ISOBAR SPINAL SYSTEM
K000425 · MNI
Encore Orthopedics, Inc.
Orthopedic · 27d
Cleared Mar 07, 2000
MODIFICATION TO EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM
K000513 · KWQ
Ebi, L.P.
Orthopedic · 20d
Cleared Mar 06, 2000
SCORPIO TOTAL STABLIZER (TS) TOTAL KNEE SYSTEM
K994128 · JWH
Howmedica Osteonics Corp.
Orthopedic · 90d
Cleared Mar 06, 2000
THE LIGAMENT ANCHOR SOFT SCREW
K994152 · HWC
Corin USA
Orthopedic · 89d
Cleared Mar 06, 2000
INSTRUMENTS FOR MINIMALLY INVASIVE SPINAL SURGERY (MISS)
K994363 · HRX
Richard Wolf Medical Instruments Corp.
Orthopedic · 70d
Cleared Mar 01, 2000
STAPLETAC2 BONE ANCHOR SYSTEM
K000279 · MBI
American Medical Systems, Inc.
Orthopedic · 30d
Cleared Mar 01, 2000
CROSS LINKED POLYETHYLENE ACETABULAR COMPONENTS,MODEL XX-YY-ZZZZZZ
K990330 · JDI
Implex Corp.
Orthopedic · 393d
Cleared Mar 01, 2000
PHALANGEAL FIXATION SYSTEM
K994232 · HTY
Medcanica, Inc.
Orthopedic · 76d
Cleared Feb 28, 2000
TRIPLE-FIX SPINAL FIXATION SYSTEM
K992147 · MNI
Advanced Spine Technology, Inc.
Orthopedic · 249d
Cleared Feb 28, 2000
BLACKSTONE SPINAL FIXATION SYSTEM
K994217 · MNH
Blackstone Medical, Inc.
Orthopedic · 75d
Cleared Feb 25, 2000
ROTAGLIDE + MODULAR KNEE SYSTEM WITH FIXED MENISCUS
K000232 · JWH
Corin USA
Orthopedic · 29d
Cleared Feb 25, 2000
EBI XFIX DFS SYSTEM
K000319 · KTT
Ebi, L.P.
Orthopedic · 23d
Cleared Feb 25, 2000
MALLORY-HEAD MODULAR CALCAR TOTAL HIP SYSTEM
K000335 · LPH
Biomet, Inc.
Orthopedic · 22d
Cleared Feb 25, 2000
RADIAL HEAD PROSTHESIS
K992220 · KWI
Smith & Nephew, Inc.
Orthopedic · 239d
Cleared Feb 25, 2000
MEMOGRAPH STAPLE, WARM SYSTEM
K993714 · JDR
Biomedical Ent., Inc.
Orthopedic · 115d
Cleared Feb 25, 2000
CORMET 2000 HEMI HIP METALLIC RESURFACING PROSTHESIS
K994153 · KXA
Corin USA
Orthopedic · 79d
Cleared Feb 25, 2000
ACUFEX SPIKED WASHER SYSTEM, ACUFEX SUTURE WASHER SYSTEM, ACUFEX CANCELLOUS...
K994202 · HWC
Smith & Nephew, Inc.
Orthopedic · 74d
Cleared Feb 18, 2000
MRS-TITAN
K992359 · LZO
Rotec Medizintechnik GmbH
Orthopedic · 219d
Cleared Feb 18, 2000
IMPLEX HEDROCEL PS TIBIAL COMPONENT, MODEL HEDROCEL POSTERIOR STABILIZED...
K994076 · JWH
Implex Corp.
Orthopedic · 78d