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
9241–9264 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Feb 19, 2009
ZIMMER NATURAL NAIL SYSTEM PIRIFORMIS FOSSA AND GREATER TROCHANTER ANTEGRADE...
K083497 · HSB
Zimmer, Inc.
Orthopedic · 86d
Cleared Feb 18, 2009
ANATOMIC LOCKING PLATING SYSTEM
K082300 · HRS
DePuy Orthopaedics, Inc.
Orthopedic · 190d
Cleared Feb 18, 2009
APEX HIP SYSTEM BIPOLAR HEAD, MODEL H3-822XX AND H3-828YY, XX=OD IN [MM]...
K082468 · KWY
Omni Life Science, Inc.
Orthopedic · 175d
Cleared Feb 13, 2009
METASURG CANNULATED TIATANIUM HEMI IMPLANT, MODEL HM-1000
K083469 · KWD
Metasurg
Orthopedic · 81d
Cleared Feb 13, 2009
LUCENT MAGNUM
K083475 · OVD
Spinal Elements, Inc.
Orthopedic · 81d
Cleared Feb 13, 2009
ORTHOPEDIC SALVAGE SYSTEM (OSS) 9CM COBALT - CHROME TIBIAL BODIES
K083827 · KRO
Biomet Manufacturing Corp
Orthopedic · 52d
Cleared Feb 12, 2009
TORNIER, INC., INSITE SUTURE ANCHORS
K083268 · MAI
Tornier, Inc.
Orthopedic · 99d
Cleared Feb 12, 2009
LDR SPINE ROI-C IMPLANT
K083857 · MQP
Ldr Spine USA
Orthopedic · 50d
Cleared Feb 11, 2009
100KGY E-POLY ACETABULAR LINERS- ADDITIONAL PROFILES: +3 MAXROM AND +3 HI-WALL
K090103 · MAY
Biomet, Inc.
Orthopedic · 27d
Cleared Feb 09, 2009
SMITH & NEPHEW SL-PLUS MIA STANDARD AND LATERAL FEMORAL HIP STEM
K082371 · LZO
Smith & Nephew, Inc.
Orthopedic · 175d
Cleared Feb 09, 2009
MASTERGRAFT RESORBABLE CERAMIC GRANULES
K082918 · MQV
Medtronic Sofamor Danek
Orthopedic · 132d
Cleared Feb 09, 2009
MODIFICATION TO DEPUY NEUFLEX PIP FINGER
K083107 · KYJ
DePuy Orthopaedics, Inc.
Orthopedic · 112d
Cleared Feb 09, 2009
INTRAMEDULLARY FIXATION ROD (IFS)
K083458 · HSB
Novalign Orthopaedics, Inc.
Orthopedic · 80d
Cleared Feb 06, 2009
DYNAMIK INTERVERTEBRAL BODY FUSION DEVICE
K081888 · MAX
Spineart
Orthopedic · 219d
Cleared Feb 06, 2009
FREEDOM TOTAL KNEE SYSTEM
K082019 · JWH
Maxx Orthopedics, Inc.
Orthopedic · 205d
Cleared Feb 06, 2009
CORRIDOR FIXATION SYSTEM
K083442 · MRW
Globus Medical, Inc.
Orthopedic · 78d
Cleared Feb 06, 2009
MEMOMETAL ANCHORAGE BONE PLATE SYSTEM, MODELS PLSS/PLSL,...
K083447 · HRS
Memometal Technologies
Orthopedic · 77d
Cleared Feb 05, 2009
NBX - NON-BRIDGING EXTERNAL FIXATOR - SHOULDER
K082833 · KTT
Nutek Orthopaedics, Inc.
Orthopedic · 132d
Cleared Feb 05, 2009
BIODRIVE CANNULATED SCREW SYSTEM
K082874 · HWC
Biomet Trauma
Orthopedic · 129d
Cleared Feb 05, 2009
SYNTHES EPOCA SHOULDER PROSTHESIS SYSTEM
K083439 · MBF
Synthes (Usa)
Orthopedic · 77d
Cleared Feb 02, 2009
LDR SPINE ROI INTERBODY FUSION SYSTEM
K082262 · MAX
Ldr Spine USA
Orthopedic · 178d
Cleared Feb 02, 2009
CARDIFF ANTERIOR CERVICAL PLATE SYSTEM
K083338 · KWQ
Seaspine, Inc.
Orthopedic · 82d
Cleared Feb 01, 2009
OLECRANAIL INTRAMEDULLARY FIXATION SYSTEM
K090091 · HSB
Mylad Orthopedic Solutions, LLC
Orthopedic · 18d
Cleared Jan 30, 2009
NOVEL SPINAL SYSTEM
K081153 · MNH
Medyssey Co, Ltd.
Orthopedic · 282d