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.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Orthopedic ×
17,816 results
10561–10584 of 17,816
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jun 06, 2006
36MM BIOLOX DELTA CERAMIC HEADS
K061312 · LZO
Biomet, Inc.
Orthopedic · 27d
Cleared Jun 06, 2006
MODIFICATION TO ENDIUS ATAVI SYSTEM
K061345 · HRX
Endius, Inc.
Orthopedic · 22d
Cleared Jun 06, 2006
LORENZ PECTUS SUPPORT BAR, TITANIUM
K061384 · HRS
Walter Lorenz Surgical, Inc.
Orthopedic · 19d
Cleared Jun 02, 2006
OSTEOMED 1ST MPJ HEMI IMPLANT SYSTEM
K060536 · KWD
Osteomed LP
Orthopedic · 94d
Cleared Jun 02, 2006
ACCIN UNI-KNEE SYSTEM
K060670 · HSX
Accin Corporation
Orthopedic · 80d
Cleared May 31, 2006
REMA SHAVER BLADES
K060172 · HRX
Rema Medizintechnik GmbH.
Orthopedic · 128d
Cleared May 31, 2006
AESCULAP BIPOLAR ACETABULAR CUP
K060707 · KWY
Aesculap, Inc.
Orthopedic · 76d
Cleared May 31, 2006
REFLECTION 3 ACETABULAR SYSTEM
K061253 · MBL
Smith & Nephew, Inc.
Orthopedic · 27d
Cleared May 30, 2006
COMPREHENSIVE PRIMARY SHOULDER STEMS
K060692 · MBF
Biomet Manufacturing Corp
Orthopedic · 76d
Cleared May 26, 2006
NEXGEN COMPLETE KNEE SOLUTION ULTRACONGRUENT (UC-FLEX) FIXED BEARING...
K060722 · JWH
Zimmer, Inc.
Orthopedic · 70d
Cleared May 26, 2006
EXCIA TOTAL HIP SYSTEM 12/14 TRUNNION WITH CERAMIC HEAD
K060918 · LZO
Aesculap, Inc.
Orthopedic · 52d
Cleared May 25, 2006
STRYKER SPINE VLIFT VERTEBRAL BODY REPLACEMENT SYSTEM
K060506 · MQP
Stryker Spine
Orthopedic · 87d
Cleared May 25, 2006
VANGUARD REMOVABLE MOLDED POLY TIBIA
K060525 · JWH
Biomet Manufacturing Corp
Orthopedic · 87d
Cleared May 25, 2006
MEMORY STAPLE
K060746 · JDR
DePuy Orthopaedics, Inc.
Orthopedic · 66d
Cleared May 25, 2006
TRABECULAR METAL ACETABULAR AUGMENTS
K061067 · LPH
Zimmer Trabecular
Orthopedic · 38d
Cleared May 25, 2006
VENTURE ANTERIOR CERVICAL PLATE SYSTEM
K061274 · KWQ
Medtronic Sofamor Danek
Orthopedic · 17d
Cleared May 24, 2006
SPACER-S TEMPORARY SHOULDER SPACER
K060535 · HSD
Tecres S.P.A.
Orthopedic · 85d
Cleared May 24, 2006
BIO 1-KIT BIOSORB FILLED CARTRIDGE
K061022 · MQV
Science For Biomaterials
Orthopedic · 41d
Cleared May 24, 2006
EBI OPTILOCK PERIARTICULAR PLATING SYSTEM
K061098 · HRS
Ebi, L.P.
Orthopedic · 35d
Cleared May 23, 2006
DENALI DEFORMITY SYSTEM
K052404 · KWP
K2m, LLC
Orthopedic · 264d
Cleared May 19, 2006
ARTHREX BIO-COMPRESSION SCREW
K060478 · HWC
Arthrex, Inc.
Orthopedic · 85d
Cleared May 19, 2006
DEPUY SOLUTION SYSTEM HIP PROSTHESIS
K060581 · LPH
DePuy Orthopaedics, Inc.
Orthopedic · 73d
Cleared May 19, 2006
ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM, SIZES 8MM AND 10MM
K060704 · PHX
Zimmer, Inc.
Orthopedic · 64d
Cleared May 19, 2006
XIA TITANIUM AND 4.5 SPINAL SYSTEMS
K060979 · NKB
Stryker Spine
Orthopedic · 39d