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
13657–13680 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Nov 20, 1998
ZETA MULTIZONE LOCKING NAIL SYSTEM
K982958 · HSB
Howmedica Corp.
Orthopedic · 88d
Cleared Nov 20, 1998
POLYMER THREADED ANCHOR / SUTURE COMBINATION
K982963 · JDI
Orthopaedic Biosystems, Ltd.
Orthopedic · 88d
Cleared Nov 19, 1998
OMI OCCIPITAL CERVICAL LOOP, MODEL A1089
K983282 · KWP
Ohio Medical Instrument Co., Inc.
Orthopedic · 62d
Cleared Nov 18, 1998
G/K SFN AND STN LOCKING NAILS
K983358 · HSB
Howmedica, Inc.
Orthopedic · 55d
Cleared Nov 12, 1998
HARRIS/GALANTE POROUS (HGP) HIP PROSTHESIS WITH CALCICOAT CERAMIC COATING
K980711 · LPH
Zimmer, Inc.
Orthopedic · 261d
Cleared Nov 12, 1998
MODIFICATION OF TOWNLEY PEDICLE SCREW PLATING SYSTEM
K983706 · KWP
Sofamor Danek USA,Inc.
Orthopedic · 22d
Cleared Nov 06, 1998
ST LEGER CEMENTED SEMI-CONSTRAINED TOTAL KNEE IMPLANT
K980999 · JWH
Instrument Makar, Inc.
Orthopedic · 233d
Cleared Nov 06, 1998
XOMED FEATHERTOUCH XPS POWER RASP ATTACHMENT
K983025 · HRX
Xomed, Inc.
Orthopedic · 67d
Cleared Nov 06, 1998
CAPITELLO-CONDYLAR TOTAL ELBOW PROSTHESIS
K983141 · JDB
Johnson & Johnson Professionals, Inc.
Orthopedic · 59d
Cleared Oct 28, 1998
DEPUY PROFILE ROUND HEAD INTERFERENCE SCREW, DEPUY PHANTOM RESORBABLE...
K982662 · HWC
DePuy Orthopaedics, Inc.
Orthopedic · 90d
Cleared Oct 27, 1998
SUMMIT ACETABULAR SYSTEM
K983014 · LPH
Johnson & Johnson Professionals, Inc.
Orthopedic · 60d
Cleared Oct 27, 1998
OSTEO DYNATROC PROXIMAL FEMORAL NAIL
K983339 · HSB
Osteonics Corp.
Orthopedic · 34d
Cleared Oct 26, 1998
SURGICAL DYNAMICS RODDING SYSTEM (PREVIOUSLY KNOWN AS THE AURORA TITANIUM...
K983197 · KWP
United States Surgical, A Division of...
Orthopedic · 45d
Cleared Oct 26, 1998
DEPUY ACE COMPOSITE LOCKING NUT
K983265 · HTN
Depuy Ace Medical Co.
Orthopedic · 39d
Cleared Oct 22, 1998
OLYMPUS ENDOSCOPIC SYSTEM LUMBAR HERNIA DISCECTOMY AND ITS ANCILLARY EQUIPMENT
K982133 · HRX
The Olympus Optical Co.
Orthopedic · 127d
Cleared Oct 21, 1998
ISOLA SPINAL SYSTEM
K980485 · MNI
Acromed Corp.
Orthopedic · 254d
Cleared Oct 21, 1998
ZETA MULTIZONE SCN LOCKING NAIL
K982873 · HSB
Howmedica Corp.
Orthopedic · 68d
Cleared Oct 21, 1998
SULZER ORTHOPEDICS FLUTED STEMS
K982903 · JWH
Sulzer Orthopedics, Inc.
Orthopedic · 64d
Cleared Oct 21, 1998
THREADED FIXATION PIN
K982931 · JDW
Sgarlato Laboratories, Inc.
Orthopedic · 62d
Cleared Oct 21, 1998
OSTEONICS EXTENDED FEMORAL BEARING HEAD
K982936 · LWJ
Osteonics Corp.
Orthopedic · 61d
Cleared Oct 21, 1998
TITANIUM INTRAMEDULLARY NAILS-VARIOUS STYLES
K982953 · HSB
Biomet, Inc.
Orthopedic · 58d
Cleared Oct 21, 1998
SYNTHES POSTERIOR UNIVERSAL SPINAL SYSTEM
K982987 · MNI
Synthes Spine
Orthopedic · 56d
Cleared Oct 21, 1998
TSRH SPINAL SYSTEM
K982990 · MNI
Sofamor Danek USA,Inc.
Orthopedic · 56d
Cleared Oct 21, 1998
BIO-ANCHOR, PRE-LOADED BIOABSORBABLE SUTURE ANCHOR
K983186 · MAI
Linvatec Corp.
Orthopedic · 40d