FDA 510(k) Regulatory Intelligence Search

Search devices, predicates, manufacturers and submission history used by regulatory affairs and medical device strategy teams.

174,883 clearances · 1976 to present · Updated monthly from FDA records

Filters: Orthopedic ×
17,766 results
13945–13968 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Aug 12, 1997
DYONICS DISPOSABLE ENDOSCOPIC SURGERY BLADES
K970511 · HRX
Smith & Nephew, Inc.
Orthopedic · 182d
Cleared Aug 12, 1997
LAPAROTOMY BLADDER NECK SUSPENSION KIT WITH BONE ANCHORS
K971796 · EZL
Louisville Laboratories, Inc.
Orthopedic · 89d
Cleared Aug 12, 1997
ALTA INTRAMEDULLARY ROD SYSTEM
K972108 · HSB
Howmedica Corp.
Orthopedic · 68d
Cleared Aug 11, 1997
ZIRCONIA CERAMIC MODULAR HEADS (NORTON ADVANCED CERAMICS)
K964431 · LZO
Biomet, Inc.
Orthopedic · 279d
Cleared Aug 11, 1997
QUICKLOCK ORTHOPAEDIC TARGETING SYSTEM
K964444 · HSB
Rdh Medical
Orthopedic · 278d
Cleared Aug 11, 1997
OSTEO KIRSCHNER WIRES
K971962 · HTY
Osteonics Corp.
Orthopedic · 75d
Cleared Aug 11, 1997
METAGEN ACTIVELOCK CERCLAGE SYSTEM
K972327 · JDQ
Pacific Materials and Interfaces
Orthopedic · 49d
Cleared Aug 11, 1997
LORENZ PECTUS SUPPORT BAR
K972420 · HRS
Walter Lorenz Surgical, Inc.
Orthopedic · 45d
Cleared Aug 07, 1997
QUATROLOC PLASMA SPRAYED FEMORAL COMPONENT
K964616 · LPH
Whiteside Biomechanics, Inc.
Orthopedic · 287d
Cleared Aug 07, 1997
RANSFORD CERVICAL FIXATION SYSTEM
K965221 · KWP
Surgicraft , Ltd.
Orthopedic · 219d
Cleared Aug 07, 1997
SELECT SHOULDER OFFSET HUMERAL HEAD COMPONENTS
K971715 · KWS
Sulzer Orthopedics, Inc.
Orthopedic · 90d
Cleared Aug 07, 1997
RECOVERY PROTRUSIO CAGE
K971890 · JDI
Biomet, Inc.
Orthopedic · 77d
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