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
8425–8448 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Dec 14, 2010
SIMMETRY SACROILIAC JOINT FUSION SYSTEM
K102907 · OUR
Zyga Technology, Inc.
Orthopedic · 74d
Cleared Dec 14, 2010
INBONE TOTAL ANKLE SYSTEM MODEL 200347902
K103374 · HSN
Wrightmedicaltechnologyinc
Orthopedic · 27d
Cleared Dec 13, 2010
BIORAPTOR CURVED 2.3 PK SUTURE ANCHORS
K102660 · MBI
Smith & Nephew Endoscopy, Inc.
Orthopedic · 89d
Cleared Dec 13, 2010
TRABECULAR METAL TIBIAL CONE AUGMENTS
K102896 · MBH
Zimmer Trabecular Metal Technology
Orthopedic · 74d
Cleared Dec 13, 2010
EXACTECH EQUINOXE R UHMWPE POSTERIOR AUGMENT PEGGED GLENOIDS TM
K103419 · KWS
Exactech, Inc.
Orthopedic · 21d
Cleared Dec 10, 2010
LIMA-LIO SMR SHOULDER SYSTEM - HUMERAL STEMS, LIMA-LIO SMR SHOULDER SYSTEM -...
K100858 · KWT
Lima-Lto S.P.A.
Orthopedic · 259d
Cleared Dec 10, 2010
DEPUY ATTUNE KNEE SYSTEM
K101433 · OIY
DePuy Orthopaedics, Inc.
Orthopedic · 203d
Cleared Dec 10, 2010
APEX SPINE SYSTEM W/ COCR RODS
K102488 · MNH
Spinecraft, LLC
Orthopedic · 101d
Cleared Dec 10, 2010
APTUS 1.5 TRILOCK
K102537 · HRS
Medartis AG
Orthopedic · 98d
Cleared Dec 10, 2010
GENESYS SPINE INTERBODY FUSION SYSTEM
K103034 · MAX
Genesys Spine
Orthopedic · 58d
Cleared Dec 09, 2010
HIP SEXTANT INSTRUMENT SYSTEM
K093491 · OSF
Surgical Planning Associates
Orthopedic · 394d
Cleared Dec 09, 2010
SELF RETAINING SOFT TISSUE RETRACTOR
K101609 · LXH
Koros USA, Inc.
Orthopedic · 184d
Cleared Dec 09, 2010
PREVISION HIP SYSTEM WITH RECON RING
K102424 · MEH
Aesculap Implant Systems, LLC
Orthopedic · 106d
Cleared Dec 09, 2010
2.4MM VA-LCP DORSAL DISTAL RADIUS PLATES
K102694 · HRS
Synthes (Usa)
Orthopedic · 80d
Cleared Dec 08, 2010
SUSPENSION ACROMIOCLAVICULAR (AC) REPAIR SYSTEM
K102143 · JDR
Suspension Orthopaedic Solutions, LLC
Orthopedic · 131d
Cleared Dec 08, 2010
OPTIGEN TOTAL KNEE SYSTEM
K102367 · JWH
U&I Corp.
Orthopedic · 110d
Cleared Dec 07, 2010
ARCOS INTERLOCKING DISTAL STEMS
K100469 · KWA
Biomet Manufacturing Corp
Orthopedic · 292d
Cleared Dec 07, 2010
S 100 PEDICLE SCREW SYSTEM
K101682 · MNI
Renovis Surgical Technologies, LLC
Orthopedic · 175d
Cleared Dec 07, 2010
VIPER SYSTEM, EXPEDIUM SYSTEM
K101993 · NKB
Depuy Spine, Inc.
Orthopedic · 145d
Cleared Dec 07, 2010
SUSPENSION CLAVICLE FRACTURE FIXATION SYSTEM
K102095 · HRS
Suspension Orthopaedic Solutions, LLC
Orthopedic · 134d
Cleared Dec 07, 2010
THE VARIA FIBULA LOCKED PLATING SYSTEM LINE EXTENSION ADDITION OF STRAIGHT...
K102282 · HRS
Howmedica Osteonics Corp., Dba...
Orthopedic · 117d
Cleared Dec 03, 2010
KLASSIC HD HIP SYSTEM
K100445 · LPH
Total Joint Orthopedics, Inc.
Orthopedic · 289d
Cleared Dec 03, 2010
ANYPLUS PEEK CAGES
K100516 · OVD
GS Medical Co., Ltd.
Orthopedic · 283d
Cleared Dec 03, 2010
BIOPRO POLAR HEAD
K100761 · KWY
Biopro, Inc.
Orthopedic · 261d