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
12385–12408 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Sep 06, 2002
STAYFUSE GT-IP
K022726 · HWC
Pioneer Surgical Technology
Orthopedic · 21d
Cleared Sep 05, 2002
ZIMMER TRABECULAR METAL MODULAR ACETABULAR SYSTEM
K021891 · LPH
Zimmer, Inc.
Orthopedic · 90d
Cleared Sep 05, 2002
HELICAL COMPRESSION ANCHOR SYSTEM, CANNULATED, MODEL 7.3MM
K022647 · HWC
Triad Medical, Inc.
Orthopedic · 27d
Cleared Aug 30, 2002
HYDROCEL VERTEBRAL BODY REPLACEMENT, MODEL 06-172-00XX1
K022563 · MQP
Implex Corp.
Orthopedic · 28d
Cleared Aug 28, 2002
MODIFICATION TO TENOR SPINAL SYSTEM
K022191 · KWP
Medtronic Sofamor Danek, Inc.
Orthopedic · 54d
Cleared Aug 28, 2002
REFLECTION MODIFIED ACETABULAR SHELLS
K022556 · LPH
Smith & Nephew, Inc.
Orthopedic · 26d
Cleared Aug 27, 2002
5.0 MM DIAMETER POLYAXIAL SCREWS (MOSS MIAMI 6.35MM SYSTEM)
K022623 · KWP
Depuyacromed
Orthopedic · 20d
Cleared Aug 26, 2002
BNF
K021782 · JDS
Aap Implantate AG
Orthopedic · 88d
Cleared Aug 26, 2002
TITANIUM ANKLE ARTHRODESIS NAIL
K021786 · HSB
Biomet, Inc.
Orthopedic · 88d
Cleared Aug 26, 2002
VERTE-STACK SPINAL SYSTEM
K021791 · MQP
Medtronic Sofamor Danek
Orthopedic · 87d
Cleared Aug 26, 2002
TEMPFIX EXTERNAL FIXATION SYSTEM
K021933 · KTT
DePuy Orthopaedics, Inc.
Orthopedic · 75d
Cleared Aug 26, 2002
S2 TIBIAL NAIL
K022481 · HSB
Howmedica Osteonics Corp.
Orthopedic · 28d
Cleared Aug 26, 2002
2MM PEDIATRIC FLEX NAIL
K022531 · HTY
Biomet, Inc.
Orthopedic · 26d
Cleared Aug 26, 2002
ACCOLADE C FEMORAL STEMS
K022555 · LZO
Howmedica Osteonics Corp.
Orthopedic · 24d
Cleared Aug 26, 2002
MODIFICATION TO AVALON CUP SYSTEM
K022711 · LPH
Orthopedic Source, Inc.
Orthopedic · 12d
Cleared Aug 23, 2002
UNI KNEE
K022437 · HRY
Encore Medical, L.P.
Orthopedic · 29d
Cleared Aug 23, 2002
ENDIUS FLEXTIP BLADE
K022578 · HRX
Endius, Inc.
Orthopedic · 18d
Cleared Aug 22, 2002
S2 FEMORAL NAIL
K022461 · HSB
Howmedica Osteonics
Orthopedic · 27d
Cleared Aug 21, 2002
BLACKSTONE SPINAL FIXATION SYSTEM STAPLE & WASHER
K022605 · KWQ
Blackstone Medical, Inc.
Orthopedic · 15d
Cleared Aug 19, 2002
TOTAL KNEE FEMORAL COMPONENT
K022010 · JWH
Smith & Nephew, Inc.
Orthopedic · 61d
Cleared Aug 16, 2002
CEMENT RESTRICTOR, SMALL AND LARGE
K021765 · JDK
Exactech, Inc.
Orthopedic · 79d
Cleared Aug 16, 2002
HA MODULAR REACH PROXIMAL POROUS AND HA MODULAR REACH COLLARED PROXIMAL...
K022463 · LPH
Biomet Orthopedics, Inc.
Orthopedic · 21d
Cleared Aug 15, 2002
FORTITUDE CEMENT RESTRICTOR
K021719 · JDK
Spinal Concepts, Inc.
Orthopedic · 84d
Cleared Aug 15, 2002
ANTERIOR STABILIZED TIBIAL BEARINGS
K022586 · JWH
Biomet Orthopedics, Inc.
Orthopedic · 10d