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
14041–14064 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Aug 07, 1997
INNOVASIVE 2.8MM AND 3.5MM ROC EZ SUTURE BONE FASTENER
K971922 · MBI
Innovasive Devices, Inc.
Orthopedic · 76d
Cleared Aug 06, 1997
IMPLEX HEP ACETABULAR CUP SYSTEM, CEMENTED
K971705 · JDI
Implex Corp.
Orthopedic · 90d
Cleared Aug 05, 1997
MEMORY STAPLE (20 SIZES AVAILABLE)
K964226 · JDR
Landos, Inc.
Orthopedic · 286d
Cleared Aug 05, 1997
STRYKER WEDGE INTERFERENCE SCREW SYSTEM
K972233 · HWC
Stryker Endoscopy
Orthopedic · 50d
Cleared Aug 01, 1997
SYNTHES(USA)TITANIUM LOCKING PLATE SYSTEM(TILPS)
K970048 · KWQ
Synthes (Usa)
Orthopedic · 207d
Cleared Jul 31, 1997
APOLLO KNEE FEMORAL SPACERS
K971770 · JWH
Sulzer Orthopedics, Inc.
Orthopedic · 79d
Cleared Jul 31, 1997
MEDIVISION ARTHROSCOP
K971996 · HRX
Medivision Scope Service Center, Inc.
Orthopedic · 62d
Cleared Jul 30, 1997
DUAL ROD ANTERIOR FIXATOR SYSTEM
K963780 · KWQ
Sofamor Danek USA,Inc.
Orthopedic · 313d
Cleared Jul 30, 1997
WHITESIDE BIOMECHANICS, INC. ZIRCONIA CERAMIC FEMORAL HEAD
K971721 · LZO
Whiteside Biomechanics, Inc.
Orthopedic · 82d
Cleared Jul 30, 1997
FASTAK SUTURE ANCHOR (11.7MM)/(7.5MM)
K971723 · MBI
Arthrex, Inc.
Orthopedic · 82d
Cleared Jul 30, 1997
ZIRCONIA CERAMIC FEMORAL HEAD (12/14 TAPER)
K971752 · LZO
Zimmer, Inc.
Orthopedic · 79d
Cleared Jul 30, 1997
VAGINAL SUTURING KIT FOR LAPAROTOMY BLADDER NECK SUSPENSION
K971791 · MBI
Louisville Laboratories, Inc.
Orthopedic · 76d
Cleared Jul 30, 1997
OSTEO CANNULATED SCREW SYSTEM
K971800 · HWC
Osteonics Corp.
Orthopedic · 76d
Cleared Jul 30, 1997
VAGINAL SUTURING KIT FOR BLADDER NECK SUSPENSION
K971802 · MBI
Louisville Laboratories, Inc.
Orthopedic · 76d
Cleared Jul 30, 1997
OSTEOLOCK ACETABULAR SHELL SYSTEM
K971854 · LPH
Howmedica Corp.
Orthopedic · 71d
Cleared Jul 24, 1997
IMPLEX CONTINUUM POROUS PATELLAR
K971789 · JWH
Implex Corp.
Orthopedic · 71d
Cleared Jul 23, 1997
ULTIMA TPS CEMENTED STEM
K965198 · KWL
Johnson & Johnson International
Orthopedic · 209d
Cleared Jul 23, 1997
MICRO-SEAL ACETABULAR SYSTEM
K971718 · LPH
Whiteside Biomechanics, Inc.
Orthopedic · 75d
Cleared Jul 18, 1997
HEMISPHERE CEMENTED CUP
K971581 · JDI
Ortho Development Corp.
Orthopedic · 79d
Cleared Jul 18, 1997
SYNTHES ELASTIC INTRAMEDULLARY NAIL (EIN) SYSTEM
K971783 · HTY
Synthes (Usa)
Orthopedic · 65d
Cleared Jul 18, 1997
ATLAS FRACTURE PROXIMAL HUMERAL NAIL
K971816 · HSB
Biomet, Inc.
Orthopedic · 63d
Cleared Jul 17, 1997
EPITEC TITANIUM IMPLANT SYSTEM FOR THE SURGICAL ANCHORING OF FACIAL PROSTHESES
K961719 · HRS
Howmedica Leibinger, Inc.
Orthopedic · 441d
Cleared Jul 17, 1997
P.F.C. SIGMA KNEE SYSTEM (SIZE 1.5)
K971189 · JWH
Johnson & Johnson Professionals, Inc.
Orthopedic · 107d
Cleared Jul 17, 1997
HOFFMANN II COMPACT EXTERNAL FIXATION SYSTEM
K971755 · JEC
Howmedica Corp.
Orthopedic · 66d