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
16129–16152 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Oct 04, 1991
FIXATION DEVICES AND BONE PLATE
K913930 · HRS
John M. Rayhack
Orthopedic · 43d
Cleared Oct 03, 1991
ITM SONIC SURGERY SYSTEM
K912931 · JDX
Buckman Co., Inc.
Orthopedic · 90d
Cleared Oct 02, 1991
MODULAR HIP SYSTEM
K912593 · JDI
Smith & Nephew Richards, Inc.
Orthopedic · 114d
Cleared Sep 27, 1991
APR COLLAR SPACER
K912916 · JDI
Intermedics Orthopedics
Orthopedic · 86d
Cleared Sep 25, 1991
SYNTHES MAXILLOFACIAL TITANIUM MICRO SET
K912932 · HRS
Synthes (Usa)
Orthopedic · 82d
Cleared Sep 24, 1991
OPTICAL CATHETER ARTHROSCOPE
K911296 · HRX
Medical Dynamics, Inc.
Orthopedic · 183d
Cleared Sep 24, 1991
FLEXMEDICS RETRACT ORTH PROBE, PETTINE BONE PROBE
K912843 · HXB
Flexmedics
Orthopedic · 90d
Cleared Sep 23, 1991
G-PIN
K911375 · HTY
Dr.M.A.Galluzzo
Orthopedic · 179d
Cleared Sep 23, 1991
ORTHOFIX UNREAMED TIBIAL NAIL SYSTEM
K912420 · HSB
Scientific Research
Orthopedic · 115d
Cleared Sep 18, 1991
PALMER ARCH SUPPRESSOR
K913347 · HRX
Smith & Nephew Dyonics, Inc.
Orthopedic · 54d
Cleared Sep 16, 1991
NATURAL-KNEE ULTRA CONGRUENT TIBIAL INSERT
K912663 · JWH
Intermedics Orthopedics
Orthopedic · 90d
Cleared Sep 11, 1991
DANEK SACRAL HOOK, MODIFICATION
K911379 · KWP
Danek Medical, Inc.
Orthopedic · 168d
Cleared Sep 10, 1991
ANATOMIC MODULAR KNEE POLYETHYLENE TIBIAL TRAY
K910940 · JWH
Depuy, Inc.
Orthopedic · 188d
Cleared Sep 10, 1991
T-BOLT AND NUT
K911306 · HTN
Danek Medical, Inc.
Orthopedic · 169d
Cleared Sep 06, 1991
TSRH OPEN HEAD BONE SCREW
K911319 · KWP
Danek Medical, Inc.
Orthopedic · 164d
Cleared Sep 06, 1991
MAY HUMERUS PLATES
K912936 · HRS
Turnkey Intergration USA, Inc.
Orthopedic · 63d
Cleared Sep 05, 1991
CASF (TM) (CONTOURED ANTERIOR SPINAL FIXATON SYS.)
K904446 · KWQ
Acromed Corp.
Orthopedic · 342d
Cleared Sep 05, 1991
MASTERPIECES(TM)/MICRO/MINI SYSTEMS
K913289 · HRS
Storz Instrument Co.
Orthopedic · 43d
Cleared Sep 04, 1991
ADG INTRAMEDULLARY BONE PLUG - VENTED
K911717 · LZN
American Design Group, Inc.
Orthopedic · 140d
Cleared Aug 29, 1991
STRYKER HIGH VACUUM BONE CEMENT MIXER/INJECT SYST
K912190 · JDZ
Stryker Corp.
Orthopedic · 104d
Cleared Aug 29, 1991
HA ANATOMIC HIP PROSTH W/ TI-NIDIUM SURF HARD PROC
K912263 · MEH
Zimmer, Inc.
Orthopedic · 99d
Cleared Aug 26, 1991
P.F.C. UNICONDYLAR KNEE SYSTEM
K910968 · HRY
Johnson & Johnson Orthopaedics, Inc.
Orthopedic · 173d
Cleared Aug 26, 1991
INTELIJET TM FLUID MANAGEMENT SYSTEM
K912453 · HRX
Smith & Nephew Dyonics, Inc.
Orthopedic · 84d
Cleared Aug 23, 1991
HUENE FIXATION SCREW
K910193 · HWC
Acu Med, Inc.
Orthopedic · 219d