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
12337–12360 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Oct 18, 2002
MODIFICATION TO EBI XFIX DFS SYSTEM
K023324 · KTT
Ebi, L.P.
Orthopedic · 14d
Cleared Oct 17, 2002
BIOSTEON CROSS PIN
K021351 · HWC
Biocomposites, Ltd.
Orthopedic · 171d
Cleared Oct 17, 2002
GMRS PRESS FIT STEMS WITH PUREFIX HA
K022403 · LZO
Howmedica Osteonics Corp.
Orthopedic · 86d
Cleared Oct 17, 2002
HOFFMANN 30 DEGREE PELVIC DOUBLE BALL JOINT
K022651 · LXT
Howmedica Osteonics Corp.
Orthopedic · 69d
Cleared Oct 17, 2002
RX 90 FEMORAL STEM AND RX 90 LATERALIZED FEMORAL STEM
K023085 · JDI
Biomet Orthopedics, Inc.
Orthopedic · 30d
Cleared Oct 17, 2002
OPTETRAK TOTAL KNEE SYSTEM OFFSET TIBIAL TRAY
K023186 · JWH
Exactech, Inc.
Orthopedic · 23d
Cleared Oct 17, 2002
OSSTAPLE
K023203 · JDR
Biomedical Ent., Inc.
Orthopedic · 22d
Cleared Oct 17, 2002
NEXGEN COMPLETE KNEE SOLUTION CRUCIATE RETAINING (CR)-FLEX FEMORAL COMPONENTS
K023211 · JWH
Zimmer, Inc.
Orthopedic · 21d
Cleared Oct 09, 2002
SMITH & NEPHEW SURETAC - EXPANDED INDICATIONS II
K020948 · JDR
Smith & Nephew, Inc.
Orthopedic · 198d
Cleared Oct 09, 2002
ACCOLADE TMZF PLUS HA 127 SIZE 0 HIP STEM
K023102 · MEH
Howmedica Osteonics Corp.
Orthopedic · 21d
Cleared Oct 09, 2002
JET-X TIN COATED HALF PINS
K023134 · JDW
Smith & Nephew, Inc.
Orthopedic · 19d
Cleared Oct 09, 2002
BOSWORTH CORACO-CLAVICULAR SCREW
K023294 · HWC
Howmedica Osteonics Corp.
Orthopedic · 7d
Cleared Oct 04, 2002
NBD CEMENT RESTRICTOR DEVICE
K021788 · JDK
New Business Development, LLC
Orthopedic · 126d
Cleared Oct 04, 2002
AXYA MODEL 3000 AXYALOOP TITANIUM BONE ANCHOR SYSTEM
K022207 · MBI
Axya Medical, Inc.
Orthopedic · 88d
Cleared Oct 04, 2002
RHS ACETABULAR COMPONENT
K022382 · LPH
Signal Medical Corp.
Orthopedic · 74d
Cleared Oct 04, 2002
MODIFICATION TO SMITH & NEPHEW TWINFIX TI QUICK T
K023021 · HWC
Smith & Nephew, Inc.
Orthopedic · 23d
Cleared Oct 04, 2002
NUGEN FX SCREW
K023022 · HWC
Bionx Implants, Inc.
Orthopedic · 23d
Cleared Oct 04, 2002
CLASSIC GREAT TOE IMPLANT
K023086 · KWH
Nexa Orthopedics, Inc.
Orthopedic · 17d
Cleared Oct 03, 2002
ARTHREX WRIST BIO-ANCHOR, MODEL AR-1322B
K022234 · HWC
Arthrex, Inc.
Orthopedic · 84d
Cleared Oct 02, 2002
ENDIUS ATAVI SYSTEM
K022199 · HRX
Endius, Inc.
Orthopedic · 89d
Cleared Oct 02, 2002
SMITH & NEPHEW HIP SYSTEM
K022902 · LPH
Smith & Nephew, Inc.
Orthopedic · 29d
Cleared Oct 02, 2002
TOTAL HIP FEMORAL HEADS AND LINERS
K022958 · JDI
Smith & Nephew, Inc.
Orthopedic · 26d
Cleared Oct 02, 2002
PROXILOCK HIP PROSTHESIS
K022966 · LWJ
Implex Corp.
Orthopedic · 26d
Cleared Sep 26, 2002
AXIAMED TRANS-SACRAL SPINAL ACCESS DEVICE
K020457 · HRX
Axiamed, Inc.
Orthopedic · 227d