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
14905–14928 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jun 12, 1995
ACUFEX PATELLAR BONE BLOCK SIZER
K944500 · HRX
Acufex Microsurgical, Inc.
Orthopedic · 271d
Cleared Jun 12, 1995
LUHR TITANIUM ALLOY PAN FIXATION SYSTEM
K945137 · HRS
Howmedica Corp.
Orthopedic · 235d
Cleared Jun 12, 1995
LUHR TITANIUM PAN FIXATION SYSTEM
K945139 · HRS
Howmedica Corp.
Orthopedic · 235d
Cleared Jun 09, 1995
KARL STORZ KNIVES, CURETTS, HOOKS, PROBES
K945891 · HRX
KARL STORZ Endoscopy-America, Inc.
Orthopedic · 190d
Cleared Jun 09, 1995
ACUFEX ENDOBUTTON PACK
K951859 · HRX
Acufex Microsurgical, Inc.
Orthopedic · 49d
Cleared Jun 08, 1995
KARL STORZ UNIDRIVE SHAVER, ARTHROSCOPY BLADES
K952192 · HRX
KARL STORZ Endoscopy-America, Inc.
Orthopedic · 30d
Cleared Jun 07, 1995
ORTHOMET HMC FEMORAL STEM COMPONENT
K936310 · LPH
Orthomet, Inc.
Orthopedic · 426d
Cleared Jun 07, 1995
OSTEONICS OMNIFIT AD HIP STEM SERIES
K940715 · LPH
Osteonics Corp.
Orthopedic · 474d
Cleared Jun 07, 1995
ULTIMA AUGMENTED UHMWPE CUP
K950563 · KWL
Johnson & Johnson Professionals, Inc.
Orthopedic · 119d
Cleared Jun 06, 1995
NATURAL-KNEE(R)/APOLLO(TM) KNEE
K935523 · JWH
Intermedics Orthopedics
Orthopedic · 565d
Cleared Jun 06, 1995
OSTEONICS OMNIFIT AD-HA HIP STEM SERIES
K941366 · MEH
Osteonics Corp.
Orthopedic · 442d
Cleared Jun 02, 1995
DAVOL ARTHRO-FLO 3
K951026 · HRX
Davol Inc., Sub. C. R. Bard, Inc.
Orthopedic · 88d
Cleared Jun 01, 1995
ACCESSORIES FOE ORTHOPEDIC SURGICAL PROCEDURES
K950592 · HRX
Eare Consulting Service
Orthopedic · 112d
Cleared Jun 01, 1995
GORE SMOOTHER GUIDED RASP
K951163 · HRX
W.L. Gore & Associates, Inc.
Orthopedic · 79d
Cleared May 31, 1995
BRYAN POSTERIOR SPINAL FIXATOR (BPSF)
K945435 · KWP
Arcan Orthopaedic Corp.
Orthopedic · 236d
Cleared May 31, 1995
CONSENSUS(TM) KNEE COBALT CHROME NONPOROUS STEMMED TIBIAL BASEPLATE
K945589 · JWH
U.S. Medical Products, Inc.
Orthopedic · 198d
Cleared May 31, 1995
S-ROM OPC (ONE-PIECE CEMENTED) II FEMORAL HIP PROSTHESIS
K951084 · JDI
Joint Medical Products Corp.
Orthopedic · 83d
Cleared May 30, 1995
INFINITY SHOULDER SYSTEM
K943908 · HSD
Wrightmedicaltechnologyinc
Orthopedic · 292d
Cleared May 30, 1995
ETHICON NONABSORBABLE SUTURE ANCHOR
K943950 · JDR
Ethicon, Inc.
Orthopedic · 288d
Cleared May 30, 1995
ISOLA OPEN AND CLOSED SCREWS
K944756 · MNH
Acromed Corp.
Orthopedic · 246d
Cleared May 30, 1995
OSTEONICS(R) CCR HIP STEM SERIES
K945574 · JDI
Osteonics Corp.
Orthopedic · 197d
Cleared May 30, 1995
ORTHOMET TITANIUM HYBRID FEMORAL STEM
K945783 · JDG
Orthomet, Inc.
Orthopedic · 186d
Cleared May 30, 1995
TOTAL SHOULDER PROSTHESIS
K950651 · KWS
Encore Orthopedics, Inc.
Orthopedic · 106d
Cleared May 25, 1995
ARTHROSCOPIC TELESCOPES
K943052 · HRX
Karl Storz Endoscopy
Orthopedic · 332d