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
8617–8640 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jul 21, 2010
ALPHATEC SPINE ANTERIOR LUMBAR PLATING SYSTEM
K101255 · KWQ
Alphatec Spine, Inc.
Orthopedic · 78d
Cleared Jul 20, 2010
AESCULAP IMPLANT SYSTEMS SIBD SPINAL SYSTEM
K100802 · OVD
Aesculap Implant Systems, Inc.
Orthopedic · 120d
Cleared Jul 20, 2010
GALLERY LAMINOPLASTY FIXATION SYSTEM
K100805 · NQW
Biomet Spine (Aka Ebi, LLC)
Orthopedic · 120d
Cleared Jul 20, 2010
CALLOS BONE VOID FILLER, SKAFFOLD NEXT GENERATION BONE VOID FILLER, OSTEO VATION
K100986 · MQV
Skeletal Kinetics, LLC
Orthopedic · 102d
Cleared Jul 19, 2010
FIXPINE II SYSTEM
K100765 · MNI
Dio Medical Co., Ltd.
Orthopedic · 124d
Cleared Jul 16, 2010
JULIET OL
K101720 · MAX
Spineart
Orthopedic · 28d
Cleared Jul 15, 2010
SMITH & NEPHEW MDF MODULAR SLEEVE
K100481 · MEH
Smith & Nephew, Inc.
Orthopedic · 147d
Cleared Jul 15, 2010
NEWFIX SCREW, WIRE AND PIN FIXARION SYSTEM
K101254 · HWC
Tecnologia Y Diseno Industrial, S.A...
Orthopedic · 72d
Cleared Jul 15, 2010
FACET SCREW SYSTEM
K101284 · MRW
Nuvasive, Inc.
Orthopedic · 69d
Cleared Jul 12, 2010
ASCENSION ANKLE FUSION NAIL SYSTEM
K100925 · HSB
Ascension Orthopedics, Inc.
Orthopedic · 101d
Cleared Jul 09, 2010
SPONDY SPINAL FIXATION SYSTEM
K100956 · MNH
Allure Spine LLC
Orthopedic · 93d
Cleared Jul 08, 2010
CARDO MEDICAL FEMORAL CEMENT RESTRICTOR, MODEL 503-MCRX
K101032 · JWH
Cardo Medical, Inc.
Orthopedic · 85d
Cleared Jul 08, 2010
MODIFICATION TO:RADIUS SPINAL SYSTEM
K101144 · NKB
Stryker Spine
Orthopedic · 76d
Cleared Jul 02, 2010
PROTOE ENDOSORB SMALL HAMMER TOE PIN
K100414 · JDW
Merete Medical GmbH
Orthopedic · 136d
Cleared Jul 02, 2010
DSS STABILIZATION SYSTEM
K101083 · NQP
Paradigm Spine, LLC
Orthopedic · 74d
Cleared Jul 01, 2010
SYNTHES MATRIX SYSTEM
K100634 · NKB
Synthes (Usa)
Orthopedic · 118d
Cleared Jul 01, 2010
TILOCK PEDICLE SCREW SYSTEM
K100757 · NKB
Genesys Spine
Orthopedic · 106d
Cleared Jul 01, 2010
SPINESMITH CYNCH SPINAL SYSTEM
K101085 · MAX
Spine Smith Partners L.P.
Orthopedic · 73d
Cleared Jul 01, 2010
GAMMA-BSM, BETA-BSM, EQUIVABONE, CARIGEN
K101557 · MQV
Etex Corp.
Orthopedic · 27d
Cleared Jun 30, 2010
S-LIF INTERVERTEBRAL BODY FUSION DEVICE
K092815 · MAX
Spinefrontier, Inc.
Orthopedic · 289d
Cleared Jun 30, 2010
PEEK PREVAIL CERVICAL INTERBODY DEVICE
K094042 · OVE
Medtronic Sofamor Danek
Orthopedic · 182d
Cleared Jun 30, 2010
TYCHE PEDICLE SCREW SYSTEM
K100373 · MNH
Kyung Won Medical Co., Ltd.
Orthopedic · 138d
Cleared Jun 30, 2010
APEX MODULAR HEAD, SIZE 28 ,32, 26 AND 40 MM+10.5 OFFSET, MODELS 302810,...
K101575 · LPH
Omnlife Science
Orthopedic · 23d
Cleared Jun 29, 2010
WRIST ARTHRODESIS NAIL SYSTEM
K092720 · HSB
Skeletal Dynamics, LLC
Orthopedic · 298d