Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Orthopedic ×
17,985 results
15649–15672 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
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
Cleared Jan 07, 1994
ES-100 ACCESSORIES
K932261 · HWE
Elekta Instruments, Inc.
Orthopedic · 262d
Cleared Jan 07, 1994
3M MAXI-DRIVER II DBATTERY POWERED SYSTEM
K932307 · KIJ
3M Health Care, Ltd.
Orthopedic · 241d
Cleared Jan 05, 1994
KINETIK GREAT TOE SYSTEM
K924724 · LZJ
Kinetikos Medical, Inc.
Orthopedic · 471d
Cleared Jan 05, 1994
PRISM BONE CEMENT MIXING SYSTEM
K925025 · JDZ
Depuy, Inc.
Orthopedic · 460d
Cleared Dec 30, 1993
PHOENIX BONE SCREWS PBS-TYPE SERIES
K930125 · HXA
Phoenix Bioengineering, Inc.
Orthopedic · 352d
Cleared Dec 15, 1993
CARAPACE STERILE CAST PADDING
K931672 · LGF
Carapace, Inc.
Orthopedic · 253d
Cleared Dec 08, 1993
MITEK SUPER QUICKANCHOR, MODIFICATION
K930893 · JDR
Mitek Surgical Products, Inc.
Orthopedic · 313d
Cleared Dec 06, 1993
SYMBIOSIS REUSABLE ARTHROSCOPIC SURGICAL INST.
K924016 · HRX
Symbiosis Corp.
Orthopedic · 482d
Cleared Nov 30, 1993
OSTEONICS UNIX UNICOMPARTMENTAL
K923011 · HRY
Osteonics Corp.
Orthopedic · 526d