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
13921–13944 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Sep 23, 1997
V40 ZIRCONIA FEMORAL HEADS
K972361 · LZO
Howmedica, Inc.
Orthopedic · 90d
Cleared Sep 19, 1997
INTER-OP HA POROUS ACETABULAR SYSTEM (HA/CSTI)
K972393 · LPH
Sulzer Orthopedics, Inc.
Orthopedic · 85d
Cleared Sep 19, 1997
DEPUY MOTECH MOSS-MIAMI SPINAL SYSTEM
K972568 · MNH
Depuy, Inc.
Orthopedic · 71d
Cleared Sep 19, 1997
ACUFEX SCREW CANNULA
K972599 · HWC
Smith & Nephew Endoscopy, Inc.
Orthopedic · 67d
Cleared Sep 19, 1997
MARCHETTI-VICENZI INTRAMEDULLARY NAIL, HUMERAL
K972692 · HSB
Zimmer, Inc.
Orthopedic · 64d
Cleared Sep 12, 1997
DEPUY DUPONT ORTHOPAEDICS FINGER JOINT PROSTHESIS
K970544 · KYJ
Depuy, Inc.
Orthopedic · 212d
Cleared Sep 11, 1997
ULTIMA AND ULTIMA LX CEMENTED FEMORAL STEM
K972435 · JDI
Johnson & Johnson Professionals, Inc.
Orthopedic · 73d
Cleared Sep 11, 1997
ALTA PLATING SYSTEM
K972479 · HRS
Howmedica Corp.
Orthopedic · 72d
Cleared Sep 10, 1997
BONE PLATE WITH CABLES
K972223 · HRS
Pioneer Surgical Technology
Orthopedic · 89d
Cleared Sep 10, 1997
OSTEO BOS SYSTEM
K972323 · HRS
Osteonics Corp.
Orthopedic · 82d
Cleared Sep 04, 1997
STRYKER SYSTEM 4000 HEAVY DUTY BATTERY POWERED EQUIPMENT
K972367 · KIJ
Stryker Instruments
Orthopedic · 71d
Cleared Sep 04, 1997
SYNTHES (USA) FLEXIBLE HUMERAL NAIL(FLEX NAIL) SYSTEM
K972516 · JDS
Synthes (Usa)
Orthopedic · 59d
Cleared Aug 29, 1997
BTI CORTICAL BONE SCREWS
K972403 · HWC
Biodynamic Technologies, Inc.
Orthopedic · 64d
Cleared Aug 29, 1997
LINK CEMENT PLUG
K972411 · LZN
Turnkey Intergration USA, Inc.
Orthopedic · 64d
Cleared Aug 26, 1997
DEPUY ACE A.I.M. TITANIUM TIBIAL NAIL
K972183 · HSB
Ace Medical Co.
Orthopedic · 77d
Cleared Aug 26, 1997
INNOVASIVE 2.3MM ROC EZ SUTURE BONE FASTENER
K972356 · MBI
Innovasive Devices, Inc.
Orthopedic · 62d
Cleared Aug 26, 1997
SURGICAL BURS AND SURGICAL DRILL BITS
K972508 · HWE
Synvasive Technology, Inc.
Orthopedic · 54d
Cleared Aug 25, 1997
REPICCI II UNICONDYLAR KNEE
K971938 · HRY
Biomet, Inc.
Orthopedic · 90d
Cleared Aug 25, 1997
OSTEO ANATOMICAL BONE PLATES
K972196 · HRS
Osteonics Corp.
Orthopedic · 76d
Cleared Aug 22, 1997
HEADLOC CERAMIC HEAD
K970675 · LZO
Ortho Development Corp.
Orthopedic · 179d
Cleared Aug 20, 1997
EBI SPINELINK SYSTEM
K971970 · MNH
Electro-Biology, Inc.
Orthopedic · 83d
Cleared Aug 19, 1997
LACTOSORB TRAUMA PLATING SYSTEM
K971870 · HRS
Biomet, Inc.
Orthopedic · 90d
Cleared Aug 14, 1997
DEPUY PROXIMAL FEMORAL REPLACEMENT PROSTHESIS
K970241 · LPH
Depuy, Inc.
Orthopedic · 204d
Cleared Aug 14, 1997
TITANIUM SPINAL ROD SYSTEM
K970635 · KWQ
Smith & Nephew, Inc., Orthopaedic Div.
Orthopedic · 175d