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
14305–14328 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Nov 14, 1996
BIOSCREW ABSORBABLE INTERFERENCE SCREW
K960652 · HWC
Linvatec Corp.
Orthopedic · 273d
Cleared Nov 14, 1996
SYNTHES STERILE DRILL BITS
K962913 · HWE
Synthes (Usa)
Orthopedic · 111d
Cleared Nov 14, 1996
DURACON POSTERIOR FEMORAL SPACER
K963242 · JWH
Howmedica Corp.
Orthopedic · 87d
Cleared Nov 14, 1996
EXACTECH ALL POLY ACETABULAR CUP
K963313 · JDI
Exactech, Inc.
Orthopedic · 84d
Cleared Nov 14, 1996
DEPUY MOTECH PEAK FIXATION SYSTEM
K963350 · HWC
Depuy, Inc.
Orthopedic · 80d
Cleared Nov 14, 1996
KSEA LARGE JOINT ARTHROSCOPY SET
K963524 · HRX
Karl Storz Endoscopy
Orthopedic · 71d
Cleared Nov 14, 1996
ACROMED PEDICLE SCREW
K963639 · KWP
Acromed Corp.
Orthopedic · 63d
Cleared Nov 13, 1996
EZ-FIX CANNULATED SCREW SYSTEM
K962706 · HWC
Biodynamic Technologies, Inc.
Orthopedic · 124d
Cleared Nov 13, 1996
LM BONE ANCHOR
K963288 · MBI
Li Medical Technologies, Inc.
Orthopedic · 84d
Cleared Nov 13, 1996
GUIDE WIRES FOR CANNULATED SCREWS
K963432 · LXT
Orthopaedic Biosystems, Ltd.
Orthopedic · 75d
Cleared Nov 12, 1996
APEX HOLE ELIMINATOR PS
K963309 · LPH
Depuy, Inc.
Orthopedic · 82d
Cleared Nov 12, 1996
SYNTHES SIMPLE SMALL EXTERNAL FIXATOR (SSEF)
K963618 · LXT
Synthes (Usa)
Orthopedic · 63d
Cleared Nov 12, 1996
LM BONE ANCHOR (ORTHOPEDICS)
K963812 · MBI
Li Medical Technologies, Inc.
Orthopedic · 64d
Cleared Nov 08, 1996
SYNTHES STERILE 4.5 MM CANNULATED SCREWS
K963172 · HWC
Synthes (Usa)
Orthopedic · 86d
Cleared Nov 08, 1996
SYNTHES STERILE 3.5 MM AND 4.0 MM CANNULATED SCREWS
K963192 · HWC
Synthes (Usa)
Orthopedic · 85d
Cleared Nov 06, 1996
MITEK MICRO ANCHOR
K962511 · MBI
Mitek Products
Orthopedic · 132d
Cleared Nov 06, 1996
P.F.C. CRUCIATE RETAING KNEE SYSTEM
K963117 · JWH
Johnson & Johnson Professionals, Inc.
Orthopedic · 86d
Cleared Nov 06, 1996
THREADED FIXATION PIN
K963433 · JDW
Orthopaedic Biosystems, Ltd.
Orthopedic · 68d
Cleared Nov 06, 1996
MONOTUBE CARBON TUBE
K963614 · JEC
Howmedica Corp.
Orthopedic · 57d
Cleared Nov 04, 1996
EZ-FIX SMALL CANNULATED SCREW SYSTEM
K962987 · HWC
Biodynamic Technologies, Inc.
Orthopedic · 95d
Cleared Nov 04, 1996
INNOVASIVE 2.8MM ROC SUTURE BONE FASTENER AND 3.5MM ROC SUTURE BONE FASTENER
K963402 · MBI
Innovasive Devices, Inc.
Orthopedic · 67d
Cleared Oct 30, 1996
RMS K-WIRE
K963367 · HTY
Rms Div.
Orthopedic · 64d
Cleared Oct 28, 1996
PATELLOFEMORAL JOINT PROSTHESIS
K962190 · KRR
Intermedics Orthopedics
Orthopedic · 144d
Cleared Oct 28, 1996
TBD
K963026 · HSB
Acu Med, Inc.
Orthopedic · 84d