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
14065–14088 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jul 16, 1997
ZIRCONIA PROZYR CERAMIC 12/14 GLOBAL TAPER (GT) FEMORAL HEADS
K971414 · LZO
Smith & Nephew, Inc., Orthopaedic Div.
Orthopedic · 91d
Cleared Jul 16, 1997
BRYAN POSTERIOR SPINAL FIXATOR (BPSF), MODIFIED
K971457 · KWP
Arcan Orthopaedic Corp.
Orthopedic · 110d
Cleared Jul 16, 1997
OSTEONICS ANTEVERTED NECK HIP STEM
K971497 · LZO
Osteonics Corp.
Orthopedic · 83d
Cleared Jul 16, 1997
P.F.C. SIGMA INSET PATELLA
K971652 · JWH
Johnson & Johnson Professionals, Inc.
Orthopedic · 71d
Cleared Jul 16, 1997
DALL-MILES HOMOGENEOUS STAINLESS STEEL CABLE AND BEADED CABLE
K971741 · JDQ
Howmedica Corp.
Orthopedic · 65d
Cleared Jul 09, 1997
34MM SCARF THREAD-HEAD(TM) SCREW
K971068 · HWC
Landos, Inc.
Orthopedic · 107d
Cleared Jul 09, 1997
TWIST-OFF (TM) SCREW
K971069 · HWC
Landos, Inc.
Orthopedic · 107d
Cleared Jul 09, 1997
SCARF THREAD-HEAD (TM) HEAD SCREW
K971070 · HWC
Landos, Inc.
Orthopedic · 107d
Cleared Jul 09, 1997
OSTEO COMPRESSION CONDYLE SCREW SYSTEM
K971321 · HRS
Osteonics Corp.
Orthopedic · 90d
Cleared Jul 09, 1997
AMS MAINSTAY UROLOGIC BONE ANCHOR
K971332 · MBI
American Medical Systems, Inc.
Orthopedic · 90d
Cleared Jul 09, 1997
BIO-INTERFERENCE SCREW, 7 MM, 8 MM, 9 MM
K971358 · MAI
Arthrex, Inc.
Orthopedic · 89d
Cleared Jul 09, 1997
OSTEONICS ALUMINA C-TAPER HEAD
K971409 · LZO
Osteonics Corp.
Orthopedic · 84d
Cleared Jul 09, 1997
HEADLOC CERAMIC HEAD
K971426 · LZO
Ortho Development Corp.
Orthopedic · 83d
Cleared Jul 09, 1997
INTERSEAL ACETABULAR SCREW HOLE PLUG
K971429 · LPH
Wrightmedicaltechnologyinc
Orthopedic · 82d
Cleared Jul 09, 1997
HEADLOC CERAMIC FEMORAL HEADS
K971435 · LZO
Ortho Development Corp.
Orthopedic · 82d
Cleared Jul 09, 1997
OSTEO COMPRESSION HIP SCREW SYSTEM
K971654 · HWC
Osteonics Corp.
Orthopedic · 64d
Cleared Jul 08, 1997
KAR
K961732 · MEH
Landos, Inc.
Orthopedic · 431d
Cleared Jul 08, 1997
DISK WHISK CUTTING DEVICE (CONICAL, ELLIPTICAL AND BALL HEAD)
K971342 · HWE
Disk Whisk, Inc.
Orthopedic · 89d
Cleared Jul 08, 1997
KINEMATIC ALL-POLYETHYLENE PATELLA WITH THREE PEGS
K971550 · JWH
Howmedica Corp.
Orthopedic · 71d
Cleared Jul 03, 1997
NATURAL-HIP SYSTEM POROUS STEM WITH HA/CSTI
K970300 · LPH
Intermedics Orthopedics
Orthopedic · 160d
Cleared Jun 27, 1997
ZIRCONIA CERAMIC FEMORAL HEADS WITH FOUNDATION FORGED, TEXTURED AND POROUS...
K965002 · LZO
Encore Orthopedics, Inc.
Orthopedic · 193d
Cleared Jun 27, 1997
ANCHORLOK AND ANCHORLOK RL SOFT TISSUE ANCHOR SYSTEM
K971282 · MBI
Wrightmedicaltechnologyinc
Orthopedic · 81d
Cleared Jun 27, 1997
LIMITED REUSE ENDOSCOPIC BLADES
K971676 · HRX
Smith & Nephew, Inc.
Orthopedic · 51d
Cleared Jun 27, 1997
J-FX CERCLAGE SYSTEM
K971682 · LRN
Johnson & Johnson Professionals, Inc.
Orthopedic · 52d