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
6721–6744 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Dec 20, 2013
MESO TENDON MATRIX
K133169 · OWY
Kensey Nash Corporation Dba Dsm...
Orthopedic · 64d
Cleared Dec 20, 2013
GMK SHORT STEM
K133630 · JWH
Medacta International
Orthopedic · 24d
Cleared Dec 20, 2013
CAPSTONE SPINAL SYSTEM
K133650 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 23d
Cleared Dec 19, 2013
STRUXXURE ANTERIOR CERVICAL PLATE AND SCREWS
K133475 · KWQ
Nexxt Spine, LLC
Orthopedic · 37d
Cleared Dec 18, 2013
ARIX HAND LOCKING SYSTEM
K132876 · HRS
Jeil Medical Corporation
Orthopedic · 96d
Cleared Dec 18, 2013
M.U.S.T. EXTENSION
K132878 · NKB
Medacta International
Orthopedic · 96d
Cleared Dec 18, 2013
AXSOS 3 TI LOCKING PLATE SYSTEM LINE EXTENSION
K133440 · HWC
Stryker Trauma AG
Orthopedic · 36d
Cleared Dec 18, 2013
APTUS CANNULATED COMPRESSION SCREWS
K133460 · HWC
Medartis AG
Orthopedic · 36d
Cleared Dec 17, 2013
VITALITE E CROSS-LINKED POLYETHYLENE ACETABULAR INSERT
K130652 · OQG
Consensus Orthopedics, Inc.
Orthopedic · 280d
Cleared Dec 17, 2013
PERFIX ILIAC SCREW SYSTEM
K132218 · MNH
U&I Corporation
Orthopedic · 153d
Cleared Dec 17, 2013
MANTIS & MANTIS REDUX SPINAL SYSTEM, RADIUS SPINAL SYSTEM, TRIO & TRIO+...
K133188 · NKB
Stryker Spine
Orthopedic · 61d
Cleared Dec 17, 2013
ZIMMER DISTAL RADIUS PLATING SYSTEM
K133246 · HRS
Zimmer, Inc.
Orthopedic · 56d
Cleared Dec 17, 2013
ST360 DEGREES SPINAL FIXATION SYSTEM
K133291 · NKB
Zimmer Spine, Inc.
Orthopedic · 53d
Cleared Dec 17, 2013
ARTHREX IBALANCE TKA SYSTEM
K133342 · JWH
Arthrex, Inc.
Orthopedic · 48d
Cleared Dec 16, 2013
MIKRON SPINAL FIXATION SYSTEM, POLYXIAL PEDICLE SCREWS, SET SCREWS,...
K130073 · MNI
Mikron Makina Sanayi VE Ticaret Ltd....
Orthopedic · 339d
Cleared Dec 16, 2013
CORIN METAFIX HIP STEM
K131952 · LZO
Corin USA
Orthopedic · 172d
Cleared Dec 16, 2013
CORIN MINIHIP STEM
K131986 · LZO
Corin USA
Orthopedic · 171d
Cleared Dec 16, 2013
DEPUY SYNTHES SPINE DENS ACCESS SYSTEM
K132910 · HWC
Synthes USA Products, LLC
Orthopedic · 90d
Cleared Dec 13, 2013
GENESYS SPINE APACHE LATERAL LUMBAR INTERBODY FUSION SYSTEM
K130913 · MAX
Genesys Spine
Orthopedic · 255d
Cleared Dec 13, 2013
CROSSCHECK PLATING SYSTEM
K132594 · HRS
Solana Surgical, LLC
Orthopedic · 116d
Cleared Dec 13, 2013
NORMED PELLEGRIN CALCANEUS STOP SCREW
K133035 · HWC
Normed Medizin-Technik GmbH
Orthopedic · 77d
Cleared Dec 11, 2013
GENESYS SPINE APACHE IBFD STAR CERVICAL SYSTEM
K130317 · ODP
Genesys Spine
Orthopedic · 306d
Cleared Dec 11, 2013
SMITH & NEPHEW PATIENT MATCHED CUTTING BLOCKS
K130708 · JWH
Smith & Nephew, Inc.
Orthopedic · 271d
Cleared Dec 11, 2013
VANGUARD XP KNEE SYSTEM
K132873 · MBH
Biomet, Inc.
Orthopedic · 89d