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
15529–15552 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Mar 22, 1994
BONE CEMENT RESTRICTOR
K926216 · JDK
Biodynamic Technologies, Inc.
Orthopedic · 467d
Cleared Mar 22, 1994
ACUFEX MENISCAL RASPS
K932460 · HRX
Acufex Microsurgical, Inc.
Orthopedic · 305d
Cleared Mar 22, 1994
ACE HUMERAL NAIL
K934643 · HSB
Ace Orthopedic Manufacturing Co.
Orthopedic · 174d
Cleared Mar 22, 1994
AIM SUPRACONDYLAR NAIL
K934962 · HSB
Ace Orthopedic Manufacturing Co.
Orthopedic · 155d
Cleared Mar 21, 1994
POROCOAT POROUS COATING
K931641 · LPH
Depuy, Inc.
Orthopedic · 353d
Cleared Mar 21, 1994
ACUFEX METAL ACL CANNULA
K932718 · HRX
Acufex Microsurgical, Inc.
Orthopedic · 290d
Cleared Mar 18, 1994
DISPOSABLE ARTHROSCOPIC ACCESSORY
K933949 · HRX
United States Surgical, A Division of...
Orthopedic · 218d
Cleared Mar 17, 1994
HA TI-FIT ACETABULAR AND FEMORAL COMPONENT
K922621 · MEH
Smith & Nephew Richards, Inc.
Orthopedic · 652d
Cleared Mar 14, 1994
SYNTHES UNREAMED HUMERAL NAIL (URHN)
K933518 · HSB
Synthes (Usa)
Orthopedic · 237d
Cleared Mar 14, 1994
GAMMA LOCKING NAIL MODIFICATION
K940286 · KTT
Howmedica, Inc.
Orthopedic · 63d
Cleared Mar 11, 1994
ARTHREX TIBIAL TUNNEL CANNULA
K930152 · HRX
Arthrex, Inc.
Orthopedic · 423d
Cleared Mar 10, 1994
PELVIC C-CLAMP
K922796 · JEC
Synthes (Usa)
Orthopedic · 639d
Cleared Mar 10, 1994
ZICONIA CERAMIC MOD HEAD(TYPE I TAPER 28/32, +6MM)
K925345 · LZO
Biomet, Inc.
Orthopedic · 504d
Cleared Mar 10, 1994
SYNTHES STERILE PINLESS EXTERNAL FIXATOR
K925460 · KTT
Synthes (Usa)
Orthopedic · 497d
Cleared Mar 10, 1994
ELITE(TM) ZIRCONIA TOTAL HIP BALL HEAD SYSTEM
K926395 · LZO
Depuy, Inc.
Orthopedic · 444d
Cleared Mar 10, 1994
SUTTER PROXIMAL INTERPHALANGEAL JOINT
K931588 · KYJ
Sutter Corp.
Orthopedic · 344d
Cleared Mar 10, 1994
OSTEONICS(R) OMNIFIT(R) NORMALIZED HIP STEM
K932519 · LZO
Osteonics Corp.
Orthopedic · 289d
Cleared Mar 10, 1994
RMHS POROUS DISTAL SLEEVE
K932574 · JDI
Smith & Nephew Richards, Inc.
Orthopedic · 287d
Cleared Mar 10, 1994
ACCESS TO SYNTHES TI-6A1-7NB UNREAMED FEMORAL NAIL
K932593 · HSB
Synthes (Usa)
Orthopedic · 286d
Cleared Mar 10, 1994
ROUNDED CANNULATED INSIDE-OUT (RCI) ACL SCREW
K932862 · HWC
Smith and Nephew Donjoy, Inc.
Orthopedic · 272d
Cleared Mar 10, 1994
ANTERIOR CRUCIATE LIGAMENT (ACL) SURGICAL INSTRUMENTATION SYSTEM
K934044 · HWC
Smith and Nephew Donjoy, Inc.
Orthopedic · 203d
Cleared Mar 10, 1994
PROFORM HIP SYSTEM
K934161 · JDO
Stelkast Company
Orthopedic · 195d
Cleared Mar 09, 1994
REPLICA(TM) TOTAL HIP SYSTEM
K926156 · LPH
Osteo Technology, Inc.
Orthopedic · 457d
Cleared Mar 09, 1994
OSTEONICS OMNIFIT FORGED HIP STEM SERIES
K933561 · JDI
Osteonics Corp.
Orthopedic · 230d