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
14809–14832 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Dec 04, 1995
REALITY LONG STEM HIP SYSTEM
K954219 · JDI
Kinamed, Inc.
Orthopedic · 87d
Cleared Dec 04, 1995
PROFORM POROUS BEADED FEMORAL STEM
K954466 · LPH
Stelkast Company
Orthopedic · 70d
Cleared Dec 04, 1995
KARL STORZ HEMPFLING DILATION SET
K954981 · HRX
KARL STORZ Endoscopy-America, Inc.
Orthopedic · 34d
Cleared Dec 04, 1995
RIGID NEUROVIEW ENDOSCOPE
K955037 · HRX
Neuro Navigational Corp.
Orthopedic · 31d
Cleared Dec 04, 1995
TAKE-APART ARTHRO-SCISSORS, GASPING, BIOPSY PUNCH FORCEPS FOR ARTHROSCOPY
K955272 · HRX
KARL STORZ Endoscopy-America, Inc.
Orthopedic · 19d
Cleared Nov 30, 1995
EXTEND HIP SYSTEM
K954288 · LPH
Wrightmedicaltechnologyinc
Orthopedic · 77d
Cleared Nov 30, 1995
OSTEONICS UNIPOLAR ENDO HEAD
K954534 · KWL
Osteonics Corp.
Orthopedic · 62d
Cleared Nov 29, 1995
CLS ACETABULAR COMPONENT (MODIFICATION)
K953688 · LZO
Intermedics Orthopedics
Orthopedic · 121d
Cleared Nov 29, 1995
WAGNER REVISION STEM (MODIFICATION)
K953689 · LZO
Intermedics Orthopedics
Orthopedic · 121d
Cleared Nov 24, 1995
CORTICELLOUS BONE SCREW
K953198 · HWC
Hayes Medical, Inc.
Orthopedic · 141d
Cleared Nov 24, 1995
SYNTHES CANNULATED ANGLE BLADE PLATE
K954289 · KTW
Synthes (Usa)
Orthopedic · 71d
Cleared Nov 22, 1995
ALPHA LONG STEM FEMORAL COMPONENT (SUBJECT TO WMTI MARKETING APPROVAL)
K951139 · JDI
Wrightmedicaltechnologyinc
Orthopedic · 254d
Cleared Nov 22, 1995
OSTEONICS SECUR-FIT HA PSL EXTRA ACETABULAR COMPONENT SYSTEM
K954023 · MEH
Osteonics Corp.
Orthopedic · 86d
Cleared Nov 21, 1995
INCLUSICE II(TM) ENDOSCOPE
K946087 · HRX
Sofamor Danek USA,Inc.
Orthopedic · 343d
Cleared Nov 21, 1995
AMSET R-F SYSTEM
K951266 · MNH
Advanced Spine Technology, Inc.
Orthopedic · 245d
Cleared Nov 21, 1995
DURACON MONOLITHIC STABILIZER FEMORAL COMPONENT
K954138 · JWH
Howmedica Corp.
Orthopedic · 81d
Cleared Nov 20, 1995
ZIMMER RECONSTRUCTION SYSTEM SYMPHYSEAL BONE PLATE
K953714 · HRS
Zimmer, Inc.
Orthopedic · 103d
Cleared Nov 16, 1995
RIZA-RIBE NEEDLE (MODIFICATION)
K954882 · HRX
R-Med, Inc.
Orthopedic · 98d
Cleared Nov 15, 1995
UNITRAX V40 MODULAR ADAPTOR
K954077 · KWL
Howmedica Corp.
Orthopedic · 77d
Cleared Nov 14, 1995
RETROGRADE KNIFE
K954507 · HRX
Phx Technologies Corp.
Orthopedic · 47d
Cleared Nov 14, 1995
RETRACTOR
K954508 · HRX
Phx Technologies Corp.
Orthopedic · 47d
Cleared Nov 14, 1995
PROBE KNIFE
K954509 · HRX
Phx Technologies Corp.
Orthopedic · 47d
Cleared Nov 14, 1995
RRIANGLE KNIFE
K954510 · HRX
Phx Technologies Corp.
Orthopedic · 47d
Cleared Nov 09, 1995
CODMAN ANTERIOR CERVICAL PLATE SYSTEM
K953730 · KWQ
Johnson & Johnson Professionals, Inc.
Orthopedic · 91d