FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Orthopedic ×
17,985 results
7201–7224 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jul 25, 2013
JONES-FX FRACTURE SYSTEM
K131620 · HWC
Instratek, Inc.
Orthopedic · 52d
Cleared Jul 25, 2013
HEALIX ADVANCE KNOTLESS BR ANCHOR (6.5MM)
K131974 · MAI
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 27d
Cleared Jul 24, 2013
REFORM PEDICLE SCREW SYSTEM
K131343 · MNI
Spinal USA
Orthopedic · 76d
Cleared Jul 23, 2013
FRAG-LOC SYSTEM
K130986 · HTN
Acumed, LLC
Orthopedic · 105d
Cleared Jul 22, 2013
4MM & 5MM FULL RADIUS BLADE PLUS, 4MM & 5MM BARREL BUR PLUS/4MM BARREL...
K131191 · HRX
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 87d
Cleared Jul 19, 2013
STABILIZ FIXATION SYSTEM - SPL LOCKING SCREW
K130731 · HRS
Stabiliz Orthopaedics, LLC
Orthopedic · 123d
Cleared Jul 19, 2013
NAVIGATION PIN
K131130 · OLO
Evergreen Orthopedic Research Lab
Orthopedic · 87d
Cleared Jul 18, 2013
ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM
K131467 · JWH
Conformis, Inc.
Orthopedic · 58d
Cleared Jul 17, 2013
LIFE SPINE PLATEAU SPACER SYSTEM
K131077 · MAX
Life Spine
Orthopedic · 91d
Cleared Jul 15, 2013
611 ANKLE FUSION NAIL
K130051 · HSB
Tornier S.A.S.
Orthopedic · 187d
Cleared Jul 15, 2013
NEOTIS
K130953 · MQV
Sbm Sciences For Bio Materials
Orthopedic · 101d
Cleared Jul 12, 2013
FACET FIXX
K131417 · MRW
Nexxt Spine, LLC
Orthopedic · 57d
Cleared Jul 12, 2013
LANX FUSION SYSTEM
K131547 · OVD
Lanx, Inc.
Orthopedic · 44d
Cleared Jul 11, 2013
NEXUS ANTERIOR CERVICAL PLATE SYSTEM
K131520 · KWQ
Core-Nexus
Orthopedic · 44d
Cleared Jul 10, 2013
FUSEFORCE IMPLANT SYSTEM
K124045 · JDR
Solana Surgical, LLC
Orthopedic · 191d
Cleared Jul 05, 2013
TRANSCORP ACIF SYSTEM
K121178 · ODP
Transcorp, Inc.
Orthopedic · 443d
Cleared Jul 05, 2013
PROPHECY INFINITY PREOPERATIVE NAVIGATION ALIGNMENT GUIDES
K131283 · HSN
Wrightmedicaltechnologyinc
Orthopedic · 60d
Cleared Jul 05, 2013
MECTALIF
K131671 · MAX
Medacta International
Orthopedic · 28d
Cleared Jul 03, 2013
DYNASTY ACETABULAR SYSTEM WITH CERAMIC
K130376 · LZO
Wrightmedicaltechnologyinc
Orthopedic · 139d
Cleared Jul 03, 2013
ARTHREX DISTAL RADIUS PLATE SYSTEM
K131474 · HRS
Arthrex, Inc.
Orthopedic · 42d
Cleared Jul 03, 2013
EMERGE MEDICAL LOCKING ONE-THIRD TUBULAR PLATE SYSTEM
K131480 · HRS
Emerge Medical
Orthopedic · 42d
Cleared Jul 03, 2013
EXACTECH EQUINOX SUPERIOR/POSTERIOR AUGMENT REVERSE SHOULDER GLENOID...
K131575 · PHX
Exactech, Inc.
Orthopedic · 33d
Cleared Jul 03, 2013
LAPIDUS PLATE, 3.5MM INLINE FUSION PLATE, 3.5MM MTP PLATE (LEFT AND RIGHT)
K131670 · HRS
Biomet, Inc.
Orthopedic · 26d
Cleared Jul 02, 2013
Y-KNOT FLEX ALL-SUTURE ANCHOR, W/ TWO #2 (5 METRIC) HI-FI SUTURES, 1.8MM
K131035 · MBI
Linvatec Corporation D/B/A Conmed...
Orthopedic · 81d