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
15433–15456 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jun 02, 1994
SOFAMOR ORFIL SPINE FIXATION SYSTEM
K934007 · KWP
Sofamor Co.
Orthopedic · 288d
Cleared May 27, 1994
SLT FEMORAL HEAD
K932222 · LZO
Dow Corning Wright
Orthopedic · 385d
Cleared May 26, 1994
POLY BLADES
K940515 · HRX
Linvatec Corp.
Orthopedic · 111d
Cleared May 19, 1994
GORE SMOOTHER II AND GORE BPTB
K941269 · HRX
W.L. Gore & Associates, Inc.
Orthopedic · 64d
Cleared May 18, 1994
S-ROM(R) ZTT(TM) ACETABULAR CUP-APICAL HOLE PLUG
K931676 · JDL
Joint Medical Products Corp.
Orthopedic · 407d
Cleared May 18, 1994
CONSENSUS HIP SYSTEM- NON-POROUS TITANIUM FEMORAL STEM
K933499 · LZO
U.S. Medical Products, Inc.
Orthopedic · 303d
Cleared May 18, 1994
KIRSCHNER ZIRCONIA FEMORAL HEAD
K934694 · LZO
Kirschner Medical Corp.
Orthopedic · 230d
Cleared May 18, 1994
ARTHROSCOPES AND ACCESSORIES
K936213 · HRX
Micro-Medical Devices, Inc.
Orthopedic · 140d
Cleared May 17, 1994
BIOSCREW ABSORBABLE INTERFERENCE SCREW
K933719 · HWC
Linvatec Corp.
Orthopedic · 288d
Cleared May 16, 1994
HOWMEDICA ACETABULAR SHELL W/SCREW HOLES
K933102 · LPH
Howmedica Corp.
Orthopedic · 326d
Cleared May 16, 1994
EUROFORM TOTAL HIP PROSTHESIS
K933567 · LZO
Landos, Inc.
Orthopedic · 298d
Cleared May 16, 1994
ACUFEX LINEAR/ROTARY INSTRUMENTS
K940981 · HRX
Acufex Microsurgical, Inc.
Orthopedic · 76d
Cleared May 16, 1994
ACUFEX(R) ARTHROPLASTY INSTRUMENTS
K940985 · HRX
Acufex Microsurgical, Inc.
Orthopedic · 76d
Cleared May 16, 1994
ACUFEX T-FIX ROTATOR CUFF GUIDE SYSTEMS
K941364 · HRX
Acufex Microsurgical, Inc.
Orthopedic · 56d
Cleared May 12, 1994
FIXATION PIN
K931697 · HTY
Orthologic Corp.
Orthopedic · 401d
Cleared May 12, 1994
IMPLEX A-230 POROUS ACETABULAR CUP SYST. CEMENTED
K932924 · LPH
Implex Corp.
Orthopedic · 331d
Cleared May 09, 1994
SELECT(R) SHOULDER ALL-POLY GLENOID
K931114 · KWT
Intermedics Orthopedics
Orthopedic · 431d
Cleared May 06, 1994
REFLECTION ACETABULAR COMPONENT
K932755 · LPH
Smith & Nephew Richards, Inc.
Orthopedic · 350d
Cleared May 06, 1994
ACUFEX ARTHROSCOPIC SHOULDER GUIDE SYSTEM
K940481 · HRX
Acufex Microsurgical, Inc.
Orthopedic · 93d
Cleared May 05, 1994
CO-CR ANSWER FEMORAL COMPONENT
K931194 · JDG
Biomet, Inc.
Orthopedic · 422d
Cleared May 04, 1994
AMSET(TM) CANNULATED BONE SCREW
K931538 · HWC
Advanced Med/Surg, Inc.
Orthopedic · 401d
Cleared May 04, 1994
CANNULATED CANCELLOUS SCREW
K931680 · HWC
Onyx Medical Corp.
Orthopedic · 394d
Cleared May 04, 1994
EPIPHYSIS PLATE
K931684 · HRS
Onyx Medical Corp.
Orthopedic · 394d
Cleared May 04, 1994
T-PLATE
K931692 · HRS
Onyx Medical Corp.
Orthopedic · 394d