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
15505–15528 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jan 26, 1994
SPONGER CABLE SYSTEM, MODIFICATION
K935481 · JDQ
Pioneer Surgical Technology
Orthopedic · 125d
Cleared Jan 26, 1994
SURGICAL ACCESSORIES COCR CABLE SYSTEM
K935592 · JDQ
Surgical Accessories, Inc.
Orthopedic · 68d
Cleared Jan 25, 1994
P.F.C. MOD TOTAL KNEE/CONDYL 3 FEM COMP TIB INSERT
K924340 · JWH
Johnson & Johnson Orthopaedics, Inc.
Orthopedic · 515d
Cleared Jan 25, 1994
TRICK MODULAR KNEE TIBIAL TRAY-POROUS
K931054 · JWH
Johnson & Johnson Orthopaedics, Inc.
Orthopedic · 330d
Cleared Jan 25, 1994
ARTHREX AR-8200 SHAVER SYSTEM
K932699 · HWE
Arthrex, Inc.
Orthopedic · 236d
Cleared Jan 25, 1994
MODIFICATION OF ANTERIOR SEGMENT ELECTRODES
K933527 · HWA
Mira, Inc.
Orthopedic · 189d
Cleared Jan 21, 1994
AMK LANDMARK REVISION KNEE SYSTEM
K925072 · JWH
Depuy, Inc.
Orthopedic · 471d
Cleared Jan 21, 1994
ACRYL-X II SYSTEM
K930629 · LZV
Sonokinetics, Inc.
Orthopedic · 347d
Cleared Jan 21, 1994
ACUFEX PRO-PAC AND ISO-PAC
K931621 · HRX
Acufex Microsurgical, Inc.
Orthopedic · 294d
Cleared Jan 21, 1994
BIO-PREP
K931846 · LXH
Biomedical Devices, Inc.
Orthopedic · 283d
Cleared Jan 21, 1994
SODEM POWER SYSTEM
K935567 · HWE
Sodemsystems
Orthopedic · 64d
Cleared Jan 07, 1994
FUTURA TEXTURE-TRAKKED TOTAL HIP STEM
K921382 · LWJ
Arthronics, Inc.
Orthopedic · 655d
Cleared Jan 07, 1994
PSL TOTAL HIP REPLACEMENT SYSTEM
K922500 · LPH
Biopro, Inc.
Orthopedic · 590d
Cleared Jan 07, 1994
PERFECTA TOTAL HIP SYSTEM
K923243 · JDI
Orthomet, Inc.
Orthopedic · 554d
Cleared Jan 07, 1994
CLARUS SERIES 2100 ENDOSCOPE
K923514 · HRX
Clarus Medical Systems, Inc.
Orthopedic · 540d
Cleared Jan 07, 1994
HYBRID FEMORAL STEM, PERFECTA TOTAL HIP SYSTEM
K925536 · KWY
Orthomet, Inc.
Orthopedic · 431d
Cleared Jan 07, 1994
BIOPRO ZIRALLOY MODULAR FEMORAL HEADS, MODIFIED
K925682 · LZO
Biopro, Inc.
Orthopedic · 427d
Cleared Jan 07, 1994
AMK LANDMARK REVISION KNEE FULL WEDGE TIBIAL TRAY
K925837 · JWH
Depuy, Inc.
Orthopedic · 415d
Cleared Jan 07, 1994
OSTEON ADAPTOR/CRADLE
K930319 · HWE
United American Medical Co., Inc.
Orthopedic · 350d
Cleared Jan 07, 1994
POWERED SURGICAL INSTRUMENT ACCESSORY
K930363 · HWE
Intenn Engineering, Inc.
Orthopedic · 346d
Cleared Jan 07, 1994
MITEK MINI ANCHOR, MODIFICATION
K930892 · JDR
Mitek Surgical Products, Inc.
Orthopedic · 339d
Cleared Jan 07, 1994
SL-PLUS & SLR-PLUS STEMS W/BIOLOX CERAMIC HEADS
K930963 · LZO
Encore Orthopedics, Inc.
Orthopedic · 317d
Cleared Jan 07, 1994
BAUMER SCREWS
K930970 · HWC
Baumer Ortopedia , Ltd.
Orthopedic · 317d
Cleared Jan 07, 1994
ACUFEX STERILE DRILLS
K931837 · HWE
Acufex Microsurgical, Inc.
Orthopedic · 269d