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
13177–13200 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Feb 03, 2000
MARATHON CROSS-LINKED POLYETHYLENE ACETABULAR CUP LINERS
K994415 · LPH
DePuy Orthopaedics, Inc.
Orthopedic · 36d
Cleared Feb 01, 2000
TAC' PIN
K993910 · JDW
New Deal, S.A.
Orthopedic · 76d
Cleared Jan 28, 2000
ARTHREX PLA TISSUETAK, MODEL # AR-1940 BU
K990340 · MAI
Arthrex, Inc.
Orthopedic · 359d
Cleared Jan 28, 2000
BIOLOX ALUMINA CERAMIC FEMORAL HEAD
K991162 · LZO
Smith & Nephew, Inc.
Orthopedic · 296d
Cleared Jan 28, 2000
RIM-FIX, ACETABULAR CUP
K993713 · JDI
Surgical Implants, Inc.
Orthopedic · 86d
Cleared Jan 21, 2000
MRP-TITAN
K992403 · LZO
Rotec Medizintechnik GmbH
Orthopedic · 186d
Cleared Jan 21, 2000
CITATION TMZF HA STEM
K993768 · MEH
Howmedica Osteonics Corp.
Orthopedic · 74d
Cleared Jan 20, 2000
EXACTECH ACUMATCH INTEGRATED HIP SYSTEM M-SERIES FEMORAL STEM COMPONENT
K993736 · LPH
Exactech, Inc.
Orthopedic · 77d
Cleared Jan 20, 2000
REVELATION POROUS HIP STEM
K994070 · LPH
Encore Orthopedics, Inc.
Orthopedic · 49d
Cleared Jan 13, 2000
BIO-ABSORBABLE CORKSCREW, MODEL AR-1920B
K990987 · MAI
Arthrex, Inc.
Orthopedic · 295d
Cleared Jan 13, 2000
MICOMED POSTERIOR DOUBLEROD SYSTEM (MPDS)
K991862 · MNI
Micomed GmbH
Orthopedic · 226d
Cleared Jan 13, 2000
SOCON SPINAL SYSTEM
K993551 · MNH
Aesculap, Inc.
Orthopedic · 86d
Cleared Jan 13, 2000
ACUMED SUTURE ANCHOR
K993657 · MBI
Acu Med, Inc.
Orthopedic · 77d
Cleared Jan 12, 2000
BIORCI SCREW
K992396 · HWC
Smith & Nephew Endoscopy, Inc.
Orthopedic · 177d
Cleared Jan 11, 2000
DEPUY ACE CALCANEAL PERI-ARTICULAR PLATE
K993465 · HRS
Depuy, Inc.
Orthopedic · 90d
Cleared Jan 10, 2000
EIS DYNAMIC MEMORY STAPLES SYSTEM
K991962 · JDR
Groupe Lepine
Orthopedic · 214d
Cleared Jan 10, 2000
TITAN RC TACK
K994269 · MAI
Innovasive Devices, Inc.
Orthopedic · 21d
Cleared Jan 07, 2000
ASCENT KNEE SYSTEM
K994326 · KWH
Biomet Manufacturing, Inc.
Orthopedic · 16d
Cleared Jan 03, 2000
ALPHATEC EXTERNAL FIXATION SYSTEM COMPRESSION/DISTRACTION ROD
K993873 · KTT
Alphatec Mfg., Inc.
Orthopedic · 49d
Cleared Dec 29, 1999
MODIFICATION TO ISOLA SPINAL SYSTEM
K993030 · KWQ
Depuyacromed
Orthopedic · 113d
Cleared Dec 27, 1999
K-CENTRUM ANTERIOR SPINAL FIXATION SYSTEM
K990959 · KWQ
Spineology, Inc.
Orthopedic · 280d
Cleared Dec 22, 1999
MODULAR REACH HIP
K994038 · LPH
Biomet, Inc.
Orthopedic · 23d
Cleared Dec 21, 1999
SYNTHES CERVIFIX SYSTEM
K994187 · KWP
Synthes (Usa)
Orthopedic · 8d
Cleared Dec 20, 1999
DURATION IV STERILIZATION PROCESS (ACETABULAR INSERTS)
K990849 · LPH
Howmedica Osteonics Corp.
Orthopedic · 280d