FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Orthopedic ×
17,850 results
11785–11808 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Oct 30, 2003
GLOBAL PRESS-FIT STEM
K032385 · LPH
Global Medical Co.
Orthopedic · 87d
Cleared Oct 24, 2003
CONVERGE RETI-LOCK MULTI-HOLE REINFORCEMENT CUP
K032348 · LZO
Centerpulse Orthopedics, Inc.
Orthopedic · 86d
Cleared Oct 22, 2003
CONKLUSION PEDICLE SCREW SYSTEM
K031455 · MNI
Signus Medical, LLC
Orthopedic · 168d
Cleared Oct 22, 2003
INTER-OS LIMB LENGTHENER
K031875 · KTT
Inter-Os Technologies
Orthopedic · 127d
Cleared Oct 22, 2003
T2 NAILING SYSTEM
K032523 · HSB
Howmedica Osteonics Corp.
Orthopedic · 68d
Cleared Oct 22, 2003
TARAS THREADED FIXATION PIN
K032532 · JDW
Union Surgical, LLC
Orthopedic · 68d
Cleared Oct 22, 2003
SYNTHES 4.0MM TITANIUM (TI.) LOCKING SCREWS
K032559 · HRS
Synthes (Usa)
Orthopedic · 64d
Cleared Oct 22, 2003
STS SCREW
K032682 · HWC
Ortho-Pro, LLC
Orthopedic · 54d
Cleared Oct 22, 2003
ASCENSION MODULAR RADIAL HEAD
K032686 · KWI
Ascension Orthopedics, Inc.
Orthopedic · 54d
Cleared Oct 22, 2003
ZIMMER M/L TAPER HIP PROSTHESIS, 7711 SERIES
K032726 · LPH
Zimmer, Inc.
Orthopedic · 49d
Cleared Oct 21, 2003
ISO-ELASTIC CERCLAGE SYSTEM
K030256 · JDQ
Kinamed, Inc.
Orthopedic · 270d
Cleared Oct 15, 2003
SC TOTAL HIP SYSTEM
K031474 · JDI
Orthopedic Alliance, LLC
Orthopedic · 159d
Cleared Oct 15, 2003
BIO-INTRAFIX TIBIAL SCREW AND SHEATH
K032167 · HWC
Mitek Worldwide
Orthopedic · 91d
Cleared Oct 15, 2003
GENESIS II POROUS PLUS HA KNEE SYSTEM
K032683 · MBH
Smith & Nephew, Inc.
Orthopedic · 47d
Cleared Oct 10, 2003
ORIA SPINAL CLIP SYSTEM, LATERAL INTERMEDIATE CONNECTOR, MODEL AL01
K031471 · KWP
Ortho Tec, LLC
Orthopedic · 154d
Cleared Oct 10, 2003
PROVEN REVISION FEMORAL AND PROVEN REVISION TIBIAL INSERT
K031901 · JWH
Stelkast Company
Orthopedic · 112d
Cleared Oct 10, 2003
KLS-MARTIN STERNAL PLATING SYSTEM
K032413 · HRS
KLS-Martin L.P.
Orthopedic · 66d
Cleared Oct 09, 2003
NEXGEN POROUS, UNCEMENTED FEMORAL AND TIBIAL BASEPLATE COMPONENTS
K031061 · MBH
Zimmer, Inc.
Orthopedic · 189d
Cleared Oct 09, 2003
SHIRAZ-JAVA SPINAL FIXATION SYSTEM
K031265 · MNH
Spine Next SA
Orthopedic · 171d
Cleared Oct 09, 2003
ACCOLADE-J HIP STEM SERIES
K032300 · MEH
Howmedica Osteonics Corp.
Orthopedic · 76d
Cleared Oct 09, 2003
SONOMA ANTERIOR CERVICAL PLATE SYSTEM
K032368 · KWQ
Seaspine
Orthopedic · 69d
Cleared Oct 09, 2003
FEP FIXATION SYSTEM AND STYLO WRIST FIXATION SYSTEM
K032427 · JEC
Meridan Medical
Orthopedic · 64d
Cleared Oct 09, 2003
GLOBAL MODULAR REPLACEMENT SYSTEM ANTEVERTED PROMIMAL FEMORAL COMPONENT
K032581 · LPH
Howmedica Osteonics Corp.
Orthopedic · 49d
Cleared Oct 09, 2003
BLACKSTONE SURGICAL TITANIUM MESH SYSTEM ANGLED END RINGS
K032700 · MQP
Blackstone Medical, Inc.
Orthopedic · 37d