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
12649–12672 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Oct 03, 2001
PRO-FEMUR
K012091 · LZO
Wrightmedicaltechnologyinc
Orthopedic · 90d
Cleared Oct 01, 2001
DYNAMIC COMPRESSION SHAPE MEMORY ALLOY (SMA) STAPLE SYSTEM
K012081 · JDR
Medtronic Sofamor Danek, Inc.
Orthopedic · 90d
Cleared Sep 28, 2001
VERTEX RECONSTRUCTION SYSTEM
K003780 · KWP
Medtronic Sofamor Danek, Inc.
Orthopedic · 295d
Cleared Sep 28, 2001
SYNTHES LOCKING DISTAL RADIUS PLATING SYSTEM
K012114 · HRS
Synthes (Usa)
Orthopedic · 84d
Cleared Sep 28, 2001
DEVICE MODIFICATION OF SILHOUETTE SPINDAL FIXATION SYSTEM
K012173 · KWP
Sulzer Spine-Tech
Orthopedic · 78d
Cleared Sep 28, 2001
STRYKER CROSS-PINNED INTERFERENCE SCREW SYSTEM
K012270 · JDW
Stryker Endoscopy
Orthopedic · 71d
Cleared Sep 27, 2001
PF2
K012062 · KTT
Fixano SA
Orthopedic · 87d
Cleared Sep 27, 2001
RADIOFIX
K012078 · KTT
Fixano SA
Orthopedic · 87d
Cleared Sep 26, 2001
THE NEXGEN TMT TIBIA, MODELS 00-5886-XXYY, 05-120-XXYY-0
K012866 · JWH
Implex Corp.
Orthopedic · 30d
Cleared Sep 24, 2001
AOS MODULAR FEMORAL NAIL
K012190 · HSB
Advanced Orthopaedic Solutions, Inc.
Orthopedic · 73d
Cleared Sep 24, 2001
XIA STAINLESS STEEL SYSTEM
K012870 · KWP
Howmedica Osteonics Corp.
Orthopedic · 28d
Cleared Sep 20, 2001
COLLAGRAFT STRIP BONE GRAFT MATRIX (FOR USE AS A BONE FILLER), MODEL 1X,3X,6X...
K000122 · MQV
Neucoll, Inc.
Orthopedic · 611d
Cleared Sep 19, 2001
IMPRO VISE ABSORBABLE CEMENT FLOW RESTRICTOR
K011943 · LZN
Kensey Nash Corp.
Orthopedic · 90d
Cleared Sep 19, 2001
SULZER ORTHOPEDICS ALLEGRETTO UNICOMPARTMENTAL KNEE
K011954 · HSX
Sulzer Orthopedics, Inc.
Orthopedic · 89d
Cleared Sep 19, 2001
CONTOUR MENISCUS ARROW, MODELS 541110, 541113, AND 541116
K012334 · MAI
Bionx Implants, Inc.
Orthopedic · 57d
Cleared Sep 17, 2001
OPUS MAGNUM ANCHOR & INSERTER
K012125 · HTY
Opus Medical, Inc.
Orthopedic · 73d
Cleared Sep 14, 2001
COPELAND MB RESURFACING HUMERAL HEADS
K010657 · HSD
Biomet Manufacturing, Inc.
Orthopedic · 192d
Cleared Sep 14, 2001
COPELAND MB/HA RESURFACING HUMERAL HEADS
K010827 · HSD
Biomet Orthopedics, Inc.
Orthopedic · 178d
Cleared Sep 13, 2001
SYNERGY TI INTEGRAL OPEN SCREWS MODELS # 6193, 6194, 6195,6196, 6173, 6174,...
K012871 · KWP
Interpore Cross Intl.
Orthopedic · 17d
Cleared Sep 12, 2001
SYNTHES (USA) TROCHANTERIC FIXATION NAIL (TFN) SYSTEM
K011857 · HSB
Synthes (Usa)
Orthopedic · 90d
Cleared Sep 11, 2001
ARTSCAN CARTILAGE STIFFNESS TESTING DEVICE
K010303 · NGR
Artscan Medical Innovations
Orthopedic · 280d
Cleared Sep 07, 2001
ORTHOGENESIS LPS PROXIMAL TIBIAL REPLACEMENT AND ORTHOGENESIS LPS TIBIAL BEARING
K011810 · KRO
Depuy, Inc.
Orthopedic · 88d
Cleared Sep 07, 2001
MPF ACETABULAR CUP
K011836 · LZO
Plus Orthopedics
Orthopedic · 87d
Cleared Sep 06, 2001
SYNTHES LCP PROXIMAL HUMERUS PLATES
K011815 · KTW
Synthes (Usa)
Orthopedic · 87d