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
14641–14664 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jan 18, 1996
PCA +15MM MODULAR FEMORAL HEAD
K955305 · MEH
Howmedica Corp.
Orthopedic · 59d
Cleared Jan 18, 1996
MICROAIRE SMARTDRIVE SYSTEM
K955591 · HWE
Microaire Surgical Instruments, Inc.
Orthopedic · 42d
Cleared Jan 17, 1996
OSTEONICS SECUR-FIT HA PLUS HIP STEM SERIES
K951517 · MEH
Osteonics Corp.
Orthopedic · 289d
Cleared Jan 17, 1996
HOWMEDICA FEMORAL & PROXIMAL TIBIAL MODULAR REPLACEMENT SYTESM
K952970 · JDI
Howmedica Corp.
Orthopedic · 204d
Cleared Jan 17, 1996
DUAL TAPER WEDGE PRESSED FIT FEMORAL COMPONENT
K953268 · LWJ
Stelkast Company
Orthopedic · 188d
Cleared Jan 17, 1996
SUTURE WASHER
K954148 · HTN
Acu Med, Inc.
Orthopedic · 134d
Cleared Jan 17, 1996
TRILOGY ACETABULAR COMPONENT 7MM OFFSET
K954698 · LPH
Zimmer, Inc.
Orthopedic · 97d
Cleared Jan 17, 1996
DEPUY ADVANTAGE HIP FEMORAL PROSTHESIS WITH POROCOAT
K954811 · LPH
Depuy, Inc.
Orthopedic · 90d
Cleared Jan 17, 1996
ASPACH 65,000 (MODIFICATION)
K955084 · HSZ
The Anspach Effort, Inc.
Orthopedic · 90d
Cleared Jan 17, 1996
KARL STORZ TARGETING UNIT
K955652 · HRX
KARL STORZ Endoscopy-America, Inc.
Orthopedic · 36d
Cleared Jan 16, 1996
TITANIUM GDLH POSTERIOR SPINAL SYSTEM
K954645 · KWP
Sofamor Danek USA,Inc.
Orthopedic · 98d
Cleared Jan 11, 1996
MONOTUBE TUBE-TO-TUBE CLAMP
K954667 · JEC
Howmedica Corp.
Orthopedic · 93d
Cleared Dec 29, 1995
MITEK GII ANCHOR
K953877 · MBI
Mitek Surgical Products, Inc.
Orthopedic · 165d
Cleared Dec 28, 1995
BETA FEMORAL HIP STEM
K945774 · JDI
Wrightmedicaltechnologyinc
Orthopedic · 398d
Cleared Dec 28, 1995
TOWNLEY ALL POLY ACETABULAR CUP
K952731 · JDI
Biologically Oriented Prostheses
Orthopedic · 196d
Cleared Dec 28, 1995
FLEXIBLE INTRAMEDULLARY REAMER
K954915 · HTO
Zimmer, Inc.
Orthopedic · 63d
Cleared Dec 28, 1995
AQUACENTER 2000 SYSTEM
K954964 · HRX
Aquarius Medical Corp.
Orthopedic · 59d
Cleared Dec 19, 1995
SENTRY(TM) ANTERIOR/POSTERIOR SPINAL SYSTEMS
K936294 · KWP
Sofamor Danek Mfg., Inc.
Orthopedic · 739d
Cleared Dec 19, 1995
CLAMP ASSEMBLY
K953599 · KWP
J.B.S., S.A.
Orthopedic · 139d
Cleared Dec 19, 1995
GO INTRAMEDULLARY NAIL LOCKING SCREW
K954511 · HWC
Genesis Orthopedics, Inc.
Orthopedic · 82d
Cleared Dec 18, 1995
ECTRA II LIGAMENT RELEASE SYSTEM
K954627 · HRX
Smith & Nephew Dyonics, Inc.
Orthopedic · 73d
Cleared Dec 18, 1995
INCL ENDOSCOPE
K955471 · HRX
Sofamor Danek USA,Inc.
Orthopedic · 69d
Cleared Dec 13, 1995
APR ACETABULAR INSERTS IOI BIPOLAR
K935585 · JDI
Intermedics Orthopedics
Orthopedic · 755d
Cleared Dec 13, 1995
SPINAL PEDICLE SCREW, FIXATION, APPLIANCE
K952298 · MNH
J.B.S., S.A.
Orthopedic · 211d