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
8737–8760 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Apr 12, 2010
DEROYAL NON-LOCKING BONE FIXATION SYSTEM
K090975 · HRS
Deroyal Industries, Inc.
Orthopedic · 371d
Cleared Apr 12, 2010
NCB PERIPROSTHETIC FEMUR POLYAXIAL LOCKING PLATE SYSTEM
K100111 · HRS
Zimmer, Inc.
Orthopedic · 88d
Cleared Apr 12, 2010
MODIFICATION TO: TRIO+SPINAL FIXATION SYSTEM
K100737 · NKB
Stryker Spine
Orthopedic · 28d
Cleared Apr 08, 2010
MYKNEE CUTTING BLOCKS
K093806 · JWH
Medacta International S.A.
Orthopedic · 118d
Cleared Apr 08, 2010
SYNTHES TOMOFIX(TM) MEIAL HIGH TIBIA PLATE, SMALL
K100676 · HRS
Synthes (Usa)
Orthopedic · 29d
Cleared Apr 07, 2010
APEX ARC HIP STEM
K090845 · LZO
Omni Life Science, Inc.
Orthopedic · 376d
Cleared Apr 07, 2010
LANX ANTERIOR PLATING SYSTEM
K092765 · KWQ
Lanx, Inc.
Orthopedic · 210d
Cleared Apr 07, 2010
ARCHIMED REMEDY CERVICAL PLATE
K100215 · KWQ
Archimed, Inc.
Orthopedic · 72d
Cleared Apr 05, 2010
MINIHIP STEM
K083312 · LZO
Corin USA
Orthopedic · 511d
Cleared Apr 05, 2010
SMITH & NEPHEW FOOTPRINT RCX PK SUTURE ANCHOR
K093935 · MBI
Smith & Nephew, Inc.
Orthopedic · 104d
Cleared Apr 05, 2010
CAS FIXATION PIN 3.2 DIA X 180 MM STR, CAS FIXATON PIN 3.2 DIA X 80 MM STR,...
K100599 · OLO
Orthosoft, Inc.
Orthopedic · 33d
Cleared Apr 02, 2010
STRYKER SONICPIN SYSTEM
K091955 · HTY
Howmedica Osteonics Corp.
Orthopedic · 275d
Cleared Apr 02, 2010
AEGIS & AEGIS II SPINAL SYSTEM
K092076 · MNI
Corentec Co., Ltd.
Orthopedic · 267d
Cleared Apr 01, 2010
SMITH & NEPHEW TWINFIX ULTRA HA SUTURE ANCHOR
K093844 · MAI
Smith & Nephew, Inc.
Orthopedic · 107d
Cleared Mar 31, 2010
LDR SPINE USA SPINE TUNE TL SPINE SYSTEM
K100575 · MNI
Ldr Spine USA
Orthopedic · 30d
Cleared Mar 29, 2010
GPC BONE PLAES AND BONE SCREW & GPC DHS/DCS PLATE SYSTEM
K092493 · HRS
Gpc Medical, Ltd.
Orthopedic · 227d
Cleared Mar 29, 2010
SYNTHES STERNAL FIXATION SYSTEM
K093772 · HRS
Synthes
Orthopedic · 111d
Cleared Mar 29, 2010
SYNTHES 3.5MM QUADRILATERAL SURFACE PLATES
K093928 · HRS
Synthes (Usa)
Orthopedic · 97d
Cleared Mar 29, 2010
APEX-LNK ACETABULAR INSERT, E, APEX-LNK ACETABULAR INSERT, F, APEX-LNK
K100555 · LPH
Omni Life Science, Inc.
Orthopedic · 28d
Cleared Mar 26, 2010
INDUS ANTERIOR CERVICAL PLATE SYSTEM
K093776 · KWQ
Spinefrontier, Inc.
Orthopedic · 108d
Cleared Mar 26, 2010
G-FORCE TI SUTURE ANCHOR SYSTEM
K100579 · MBI
Wrightmedicaltechnologyinc
Orthopedic · 24d
Cleared Mar 24, 2010
BI-OSTETIC FOAM AND PUTTY, GENEROS FOAM AND PUTTY
K092046 · MQV
Berkeley Advanced Biomaterials, Inc.
Orthopedic · 261d
Cleared Mar 24, 2010
INCITE INNOVATION STAND ALONE INTERBODY FUSION DEVICE
K093808 · OVD
Incite Innovation, LLC
Orthopedic · 103d
Cleared Mar 22, 2010
KNEEALIGN SYSTEM WITH REFERENCE SENSOR
K093998 · OLO
Orthalign, Inc.
Orthopedic · 84d