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
12097–12120 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jan 28, 2003
MONARCH SPINE SYSTEM
K024348 · MNH
Depuyacromed
Orthopedic · 29d
Cleared Jan 23, 2003
INTERPORE CROSS INTERNATIONAL ANTERIOR FIXATION DEVICE (AFD)
K022143 · MQP
Interpore Cross Intl.
Orthopedic · 205d
Cleared Jan 23, 2003
SMITH & NEPHEW GLOBAL BIPOLAR SYSTEM
K023743 · KWY
Smith & Nephew, Inc.
Orthopedic · 77d
Cleared Jan 23, 2003
MOSS MIAMI SPINAL SYSTEM PIN NUT
K023804 · KWP
Depuyacromed
Orthopedic · 70d
Cleared Jan 23, 2003
SYNTHES TOMOFIX OSTEOTOMY SYSTEM
K023941 · KTT
Synthes (Usa)
Orthopedic · 58d
Cleared Jan 23, 2003
OSTEO-CABLE SLEEVE
K024022 · HXN
Biomet, Inc.
Orthopedic · 49d
Cleared Jan 23, 2003
SPINAL CONCEPTS, INC. ANT-CER DYNAMIC ANTERIOR CERVICAL PLATE SYSTEM
K024326 · KWQ
Spinal Concepts, Inc.
Orthopedic · 28d
Cleared Jan 23, 2003
FREEDOM CONSTRAINED LINERS
K030047 · KWZ
Biomet, Inc.
Orthopedic · 17d
Cleared Jan 22, 2003
MODIFICATION TO EBI XFIX DFS SYSTEM METAPHYSEAL CORRECTION SYSTEM
K024248 · KTT
Ebi, L.P.
Orthopedic · 30d
Cleared Jan 17, 2003
NATURAL-KNEE II CEMENTED MODULAR TIBIAL BASEPLATE
K023528 · JWH
Centerplus Orthopedics, Inc.
Orthopedic · 88d
Cleared Jan 17, 2003
LESSER METATARSAL PHALANGEAL JOINT IMPLANT
K023531 · KWH
Nexa Orthopedics, Inc.
Orthopedic · 88d
Cleared Jan 17, 2003
MAXIM ACCEL KNEE SYSTEM
K023546 · JWH
Biomet, Inc.
Orthopedic · 87d
Cleared Jan 15, 2003
MODIFICATION TO EBI XFIX DFS SYSTEM
K024129 · KTT
Ebi, L.P.
Orthopedic · 30d
Cleared Jan 15, 2003
UNI HIP STEM
K024134 · LWJ
Plus Orthopedics
Orthopedic · 30d
Cleared Jan 15, 2003
NEXGEN COMPLETE KNEE SOLUTION - TRABECULAR METAL AUGMENTS
K024161 · JWH
Implex Corp.
Orthopedic · 29d
Cleared Jan 09, 2003
CEM-OSTETIC, MODELS CEMO-020O, CEMO-05P, CEMO-10P, CEMO-20P, AND CEMO-30P
K022622 · MQV
Berkeley Advanced Biomaterials, Inc.
Orthopedic · 155d
Cleared Jan 09, 2003
PROPELLER HEAD SMALL CANNULATED SCREW SYSTEM
K024086 · HWC
Biomet Orthopedics, Inc.
Orthopedic · 29d
Cleared Dec 30, 2002
NARROW ASCENT INTERLOK FEMORAL COMPONENTS
K024037 · JWH
Biomet, Inc.
Orthopedic · 24d
Cleared Dec 27, 2002
MITEK RAPIDLOC-PDS MENISCAL REPAIR SYSTEM
K023388 · JDR
Mitek Worldwide
Orthopedic · 79d
Cleared Dec 24, 2002
TELEGRAPH HUMERAL NAIL
K023241 · HSB
Fournitures Hospitalieres Industrie
Orthopedic · 85d
Cleared Dec 24, 2002
RT-PLUS SOLUTION & RT-PLUS MODULAR SOLUTION KNEE
K023667 · KRO
Plus Orthopedics
Orthopedic · 54d
Cleared Dec 20, 2002
TRILOGY ACETABULAR SYSTEM CONSTRAINED LINER, MODEL 6154 SERIES
K021826 · KWZ
Zimmer, Inc.
Orthopedic · 199d
Cleared Dec 20, 2002
MITEK PDS/PGA STAPLE
K021953 · JDR
Mitek Worldwide
Orthopedic · 190d
Cleared Dec 20, 2002
COAPT SYSTEMS ENDOTINE DEVICE, MODEL CFD-101-00197
K023922 · HWC
Coapt Systems, Inc.
Orthopedic · 25d