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
13345–13368 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jul 30, 1999
LACTOSORB HAND SYSTEM
K991763 · HRS
Biomet, Inc.
Orthopedic · 67d
Cleared Jul 30, 1999
STAPLETAC BONE ANCHOR SYSTEM
K992277 · HWC
Influence, Inc.
Orthopedic · 23d
Cleared Jul 30, 1999
OSTEONICS ACCP SYSTEM LINE EXTENSION
K992344 · KWQ
Howmedica Osteonics Corp.
Orthopedic · 16d
Cleared Jul 28, 1999
PERFORMANCE KNEE SYSTEM
K992167 · JWH
Biomet, Inc.
Orthopedic · 30d
Cleared Jul 23, 1999
OSTEONICS HA-COATED DEVICES
K980070 · MEH
Osteonics Corp.
Orthopedic · 561d
Cleared Jul 23, 1999
SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM)
K991586 · KWP
Osteotech, Inc.
Orthopedic · 77d
Cleared Jul 22, 1999
TRANSFX MULTI PIN CLAMP
K991723 · LXT
Immedica, Inc.
Orthopedic · 63d
Cleared Jul 21, 1999
EMS SWISS ORTHOCLAST
K991588 · HSZ
(Ems Sa) Electro Medical Systems
Orthopedic · 75d
Cleared Jul 20, 1999
OSTEONICS SOLAR SHOULDER BIPOLAR SYSTEM
K990712 · MJT
Howmedica Osteonics Corp.
Orthopedic · 138d
Cleared Jul 15, 1999
E9000 SYSTEM
K990524 · HRX
Linvatec Corp.
Orthopedic · 146d
Cleared Jul 14, 1999
SPIN SNAP-OFF SCREW
K991477 · HWC
New Deal, S.A.
Orthopedic · 77d
Cleared Jul 14, 1999
26 MM CAST COCR HEAD AND POLYETHYLENE ACETABULAR SHELL LINER
K991622 · JDI
Stelkast Company
Orthopedic · 64d
Cleared Jul 14, 1999
DEPUY ROCKWOOD CLAVICLE PIN
K991649 · JDW
Depuy, Inc.
Orthopedic · 62d
Cleared Jul 14, 1999
COBREX HIP STEM, MODEL 01-128-XXXXX
K991869 · JDI
Implex Corp.
Orthopedic · 43d
Cleared Jul 12, 1999
TRILOGY ACETABULAR SYSTEM LONGEVITY CROSSLINKED POLYETHYLENE
K990135 · LPH
Zimmer, Inc.
Orthopedic · 180d
Cleared Jul 12, 1999
SYNERGY POROUS SIZE 8 HIP STEM
K991485 · LPH
Smith & Nephew, Inc.
Orthopedic · 75d
Cleared Jul 12, 1999
GLOBAL ADVANTAGE SHOULDER, GLOBAL ADVANTAGE HUMERAL STEM, GLOBAL ADVANTAGE...
K992065 · KWS
DePuy Orthopaedics, Inc.
Orthopedic · 24d
Cleared Jul 08, 1999
STAINLESS STEEL SOFT SUTURE WIRE
K990355 · LRN
Bregma International Trading Company...
Orthopedic · 153d
Cleared Jul 08, 1999
TITANIUM LOW PROFILE SCREWS
K991807 · LPH
Biomet, Inc.
Orthopedic · 43d
Cleared Jul 01, 1999
HEDROCEL ACETABULAR CAGE SYSTEM
K983837 · LPH
Implex Corp.
Orthopedic · 244d
Cleared Jul 01, 1999
BIO-INTERFERENCE SCREW
K990454 · HWC
Innovasive Devices, Inc.
Orthopedic · 139d
Cleared Jul 01, 1999
SYNTHES CERVIFIX SYSTEM
K990965 · KWP
Synthes (Usa)
Orthopedic · 101d
Cleared Jul 01, 1999
BI-METRIC CCOCR HEAD/NECK REPLACEMENT SYSTEM
K992058 · JDI
Biomet, Inc.
Orthopedic · 13d
Cleared Jun 29, 1999
OMNI-FIX, HUMERAL NAIL
K991405 · KTW
Turnkey Intergration USA, Inc.
Orthopedic · 68d