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
15313–15336 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Oct 06, 1994
P.F.C. 2 TOTAL HIP SYSTEM POROUS COATED MODULAR FEMORAL COMPONENT
K935452 · LZO
Johnson & Johnson Orthopaedics, Inc.
Orthopedic · 328d
Cleared Oct 06, 1994
APR ACETABULAR INSERT
K941617 · JDI
Intermedics Orthopedics
Orthopedic · 185d
Cleared Oct 05, 1994
ORTHOLOC ADVANTIM PS LSI TIBIAL INSERT
K940235 · JWH
Wrightmedicaltechnologyinc
Orthopedic · 260d
Cleared Oct 05, 1994
OPTION SHELL
K942406 · JDI
Intermedics Orthopedics
Orthopedic · 138d
Cleared Oct 04, 1994
SPINE-TECH LAPAROSCOPIC INSTRUMENTATION SYSTEM
K940913 · HRX
Spine-Tech, Inc.
Orthopedic · 221d
Cleared Oct 04, 1994
APR II FEMORAL COMPONENT (VARIOUS)
K942330 · LZO
Intermedics Orthopedics
Orthopedic · 141d
Cleared Oct 04, 1994
OSTEONICS SECURE-FIT AD ACETABULAR COMPONENT SYSTEM
K943054 · LPH
Osteonics Corp.
Orthopedic · 99d
Cleared Oct 03, 1994
S-ROM NOILES CRUCIATE RETAINING KNEE
K936037 · JWH
Joint Medical Products Corp.
Orthopedic · 287d
Cleared Oct 03, 1994
TRUE/LOK MONOLATERAL/BILATERAL FIXATOR
K941048 · LXT
Applied Osteo Systems, Inc.
Orthopedic · 210d
Cleared Oct 03, 1994
K-WIRES AND STEINMANN PINS
K941434 · HTY
Omega Surgical Instruments, Inc.
Orthopedic · 193d
Cleared Sep 30, 1994
4-LEAD IRRIGATION SET
K942101 · HRX
Douglas Medical Products Corp.
Orthopedic · 151d
Cleared Sep 30, 1994
INTERFERENCE SCREW
K943160 · HWC
Applied Osteo Systems, Inc.
Orthopedic · 91d
Cleared Sep 29, 1994
ULTIMA UNIPOLAR MODULAR HEAD
K940190 · KWL
Johnson & Johnson Orthopaedics, Inc.
Orthopedic · 259d
Cleared Sep 28, 1994
ALPHATEC 130-150 SLOTTED COMPRESSION HIP SCREW
K926417 · KTT
Alphatec Mfg., Inc.
Orthopedic · 644d
Cleared Sep 28, 1994
P.F.C. CERAMIC HIP HEAD
K933275 · LZO
Johnson & Johnson Orthopaedics, Inc.
Orthopedic · 449d
Cleared Sep 28, 1994
ACUFEX ACL SHEATH FOR INTERFERENCE SCREWS
K940290 · HRX
Acufex Microsurgical, Inc.
Orthopedic · 250d
Cleared Sep 28, 1994
CURVED ROTATABLE DISPOSABLE ARTHROSCOPIC SURGERY BLADES
K941036 · HRX
Smith & Nephew, Inc.
Orthopedic · 205d
Cleared Sep 28, 1994
PRECISION OSTELOCK SP FEMORAL COMPONENT
K941141 · LPH
Howmedica Corp.
Orthopedic · 202d
Cleared Sep 28, 1994
LMT ARTHROSCOPIC SUTURING INSTRUMENTS
K941964 · HRX
Li Medical Technologies, Inc.
Orthopedic · 159d
Cleared Sep 28, 1994
MANUAL SURGICAL INSTRUMENTS
K942079 · HRX
Acufex Microsurgical, Inc.
Orthopedic · 152d
Cleared Sep 28, 1994
INFINITY REVISION HIP STEM
K942115 · LPH
Wrightmedicaltechnologyinc
Orthopedic · 148d
Cleared Sep 28, 1994
FOUNDATION ALL POLY CUP
K942611 · JDI
Encore Orthopedics, Inc.
Orthopedic · 118d
Cleared Sep 28, 1994
ACUFEX UNI-CUT 4. OMM CARPAL TUNNEL CANNULA
K942834 · HRX
Acufex Microsurgical, Inc.
Orthopedic · 105d
Cleared Sep 28, 1994
ACUFEX(R) ENDO-FEMORAL AIMER
K942846 · HRX
Acufex Microsurgical, Inc.
Orthopedic · 104d