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
7513–7536 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Dec 13, 2012
MILAGRO INTERFERENCE SCREWS
K122869 · MAI
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 85d
Cleared Dec 12, 2012
MALIBU SPINAL SYSTEM WITH THE DAYTONA DEFORMITY SYSTEM
K122571 · NKB
Seaspine, Inc.
Orthopedic · 111d
Cleared Dec 12, 2012
S4 SPINAL SYSTEM
K123352 · NKB
Aesculap Implant Systems, Inc.
Orthopedic · 42d
Cleared Dec 11, 2012
NCS FISH-FIT MD SYSTEM FISH-FIT MD COMPASS MD
K120356 · MBI
Ncs Lab Srl
Orthopedic · 309d
Cleared Dec 11, 2012
PBP TOTAL HIP SYSTEM
K122158 · OQG
Pipeline Biomedical Products, LLC
Orthopedic · 144d
Cleared Dec 10, 2012
EMERGE MEDICAL SOLID BONE SCREWS
K122489 · HWC
Emerge Medical
Orthopedic · 117d
Cleared Dec 07, 2012
LOQTEQ PROXIMAL HUMERUS PLATE 3.5, SHORT LOQTEQ PROXIMAL HUMERUS PLATE 3.5, LONG
K121495 · HRS
Aap Implantate AG
Orthopedic · 200d
Cleared Dec 07, 2012
V2F ANTERIOR FIXATION SYSTEM
K122733 · KWQ
Zimmer Spine, Inc.
Orthopedic · 92d
Cleared Dec 07, 2012
NUVASIVE BENDINI SPINAL ROD BENDING SYSTEM
K122742 · OLO
Nuvasive, Inc.
Orthopedic · 91d
Cleared Dec 07, 2012
ES2 SPINAL SYSTEM MODEL 48280XXXX
K122845 · NKB
Stryker Spine
Orthopedic · 81d
Cleared Dec 07, 2012
XTOOL
K122861 · HRX
Ouroboros Medical
Orthopedic · 80d
Cleared Dec 06, 2012
EXACTECH EQUINOXE SHOULDER SYSTEM TORQUE DEFINING SCREW AND SHORT REPLICATOR...
K121067 · PHX
Exactech, Inc.
Orthopedic · 244d
Cleared Dec 06, 2012
PATRIOT SPACERS
K122097 · MAX
Globus Medical, Inc.
Orthopedic · 143d
Cleared Dec 05, 2012
ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM
K121640 · JWH
Materialise NV
Orthopedic · 184d
Cleared Dec 05, 2012
IN:C2 SPINAL FIXATION SYSTEM
K122630 · OVE
Spine Smith Partners L.P.
Orthopedic · 99d
Cleared Dec 05, 2012
ZIMMER PERSONA THE PERSONALIZED KNEE SYSTEM
K122745 · MBH
Zimmer, Inc.
Orthopedic · 89d
Cleared Dec 03, 2012
ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM, NON-POROUS HUMERAL STEMS
K122692 · PHX
Zimmer, Inc.
Orthopedic · 90d
Cleared Dec 03, 2012
GALLEON PEDICLE SCREW SYSTEM
K122814 · MNH
Everest Spine, LLC
Orthopedic · 81d
Cleared Dec 03, 2012
FIREBIRD SPINAL FIXATION SYSTEM, PHOENIX MIS SPINAL FIXATION SYSTEM
K122901 · NKB
Orthofix
Orthopedic · 73d
Cleared Dec 03, 2012
POLARIS SPINAL SYSTEM - BALLISTA II RODS
K123451 · NKB
Biomet Spine (Aka Ebi, LLC)
Orthopedic · 24d
Cleared Nov 30, 2012
NAVIOPFS
K121936 · OLO
Blue Belt Technologies, Inc.
Orthopedic · 151d
Cleared Nov 30, 2012
SMARTTOOLS KNEE SYSTEM
K122326 · OLO
Zimmer
Orthopedic · 121d
Cleared Nov 29, 2012
CONSTRUX MINI PEEK TI SPACER SYSTEM
K121649 · ODP
Orthofix
Orthopedic · 177d
Cleared Nov 29, 2012
PRIMALIF TM LLIF UNITARY PEEK LATERAL LUMBAR INTERBODY FUSION SYSTEM
K123207 · MAX
Osteomed LP
Orthopedic · 48d