FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Orthopedic ×
17,850 results
13801–13824 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared May 18, 1998
SEGMENTAL DEFECT REPLACEMENT SYSTEM
K980609 · HSB
Metagen, LLC
Orthopedic · 90d
Cleared May 11, 1998
DEPUY ORTHOTECH CATERA SUTURE ANCHOR
K980595 · MBI
DePuy Orthopaedics, Inc.
Orthopedic · 83d
Cleared May 11, 1998
SYNTHES SPINE UNIVERSAL SPINAL HOOK, ROD, PEDICLE/SACRAL SCREW FIXATION SYSTEM
K980928 · KWP
Synthes Spine
Orthopedic · 61d
Cleared May 11, 1998
OSTEO 4.0MM CANNULATED SCREW SYSTEM
K981259 · HWC
Osteonics Corp.
Orthopedic · 35d
Cleared May 11, 1998
SYNTHES 3.0 MM PC-FIX SYSTEM
K981372 · HWC
Synthes (Usa)
Orthopedic · 25d
Cleared May 05, 1998
BIOMET BIAXIAL TOTAL ELBOW
K980428 · JDC
Biomet, Inc.
Orthopedic · 90d
Cleared May 05, 1998
OSTEONICS TOTAL ELBOW SYSTEM
K980502 · JDC
Osteonics Corp.
Orthopedic · 85d
Cleared May 05, 1998
OSTEONICS FX-CABLELOK GRIP COMPONENTS
K980594 · LYT
Osteonics Corp.
Orthopedic · 77d
Cleared May 01, 1998
GII SPINAL FIXATION SYSTEM
K980852 · MNH
Karen E. Warden, M.E.B.E.
Orthopedic · 57d
Cleared Apr 29, 1998
HOWMEDICA AND HOWMEDICA LEIBINGER BONE SCREW WASHERS
K980364 · HWC
Howmedica Corp.
Orthopedic · 90d
Cleared Apr 29, 1998
INNOVASIVE LINX TIBIAL LIGAMENT FASTENER
K980491 · MBI
Innovasive Devices, Inc.
Orthopedic · 79d
Cleared Apr 29, 1998
THE NUFFIELD TOTAL KNEE SYSTEM
K980545 · JWH
Corin USA
Orthopedic · 76d
Cleared Apr 29, 1998
INNOVASIVE DEVICES MENISCAL SCREW
K980681 · HWC
Innovasive Devices, Inc.
Orthopedic · 68d
Cleared Apr 29, 1998
OSTEONICS GAP-II RESTORATION ACETABULAR SHELLS
K980774 · LZO
Osteonics Corp.
Orthopedic · 58d
Cleared Apr 29, 1998
ACROMED TIMX PLATE BASED LOW BACK SYSTEM
K981274 · MNH
Acromed Corp.
Orthopedic · 21d
Cleared Apr 27, 1998
INNOVASIVE 10MM LINX HT LIGAMENT FASTENER
K980334 · MBI
Innovasive Devices, Inc.
Orthopedic · 89d
Cleared Apr 27, 1998
SYNTHES SCHUHLI IMPLANT SYSTEM
K980944 · HTN
Synthes (Usa)
Orthopedic · 46d
Cleared Apr 24, 1998
ACL CLIP-IN PLATE
K973874 · MBI
Innovasive Devices, Inc.
Orthopedic · 196d
Cleared Apr 24, 1998
STELKAST PROVEN CEMENTED, SEMI-CONSTRAINED TOTAL KNEE SYSTEM
K980276 · JWH
Stelkast Company
Orthopedic · 88d
Cleared Apr 16, 1998
HARPOON SUTURE ANCHORS
K973775 · MBI
Biomet, Inc.
Orthopedic · 195d
Cleared Apr 16, 1998
MITEK BTB ABSORBABLE (PLA) CROSS PIN
K974341 · HTY
Mitek Products
Orthopedic · 149d
Cleared Apr 16, 1998
PARTNERSHIP CALCAR FEMORAL COMPONENTS
K980239 · LZO
Howmedica, Inc.
Orthopedic · 83d
Cleared Apr 16, 1998
SYNTHES SPINE POSTERIOR CERVICAL/THORACIC HOOK/ROD SYSTEM
K980358 · KWP
Synthes (Usa)
Orthopedic · 77d
Cleared Apr 16, 1998
PRESS-FIT STEM
K980473 · LZO
Encore Orthopedics, Inc.
Orthopedic · 69d