FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Orthopedic ×
17,850 results
15457–15480 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Feb 22, 1994
CERCLAGE WIRE CRIMP SLEEVE
K931246 · JDQ
Acu Med, Inc.
Orthopedic · 348d
Cleared Feb 22, 1994
TEXAS SCOTTISH RITE EASY/LOCK FIXATOR
K931578 · JEC
Applied Osteo Systems, Inc.
Orthopedic · 329d
Cleared Feb 22, 1994
INTERMEDICS ORTHOPEDICS DRILL BITS
K931734 · HWE
Intermedics Orthopedics
Orthopedic · 321d
Cleared Feb 22, 1994
THE MODULAR NAIL
K933027 · HSB
Smith & Nephew Richards, Inc.
Orthopedic · 245d
Cleared Feb 22, 1994
ACUMED RADIUS ROD
K933361 · HSB
Acu Med, Inc.
Orthopedic · 228d
Cleared Feb 22, 1994
TRUE/FLEX CLAVICLE RODS
K934148 · HSB
Applied Osteo Systems, Inc.
Orthopedic · 181d
Cleared Feb 22, 1994
SURGICAL ACCESSORIES LOOPED WIRE
K934176 · JDQ
Surgical Accessories, Inc.
Orthopedic · 179d
Cleared Feb 22, 1994
PCA ACETABULAR INSERT II, ADDITIONAL SIZES, STYLES
K934440 · JDL
Howmedica Corp.
Orthopedic · 231d
Cleared Feb 22, 1994
HOWMEDICA MONO-TUBE SINGLE PIN CLAMP
K934698 · JEC
Howmedica Corp.
Orthopedic · 145d
Cleared Feb 22, 1994
ACE UNILATERAL FIXATOR II
K936045 · JEC
Ace Orthopedic Manufacturing Co.
Orthopedic · 64d
Cleared Feb 22, 1994
HOWMEDICA MONOTUBE T-CONNECTOR
K936124 · JEC
Howmedica, Inc.
Orthopedic · 61d
Cleared Feb 22, 1994
TAVA K-WIRE
K940109 · HTY
Tava Surgical Instruments
Orthopedic · 43d
Cleared Feb 17, 1994
ARTHRO FMS 4
K925160 · HRX
Orthoconcept, Inc.
Orthopedic · 492d
Cleared Feb 17, 1994
6.5 MM CANCELLOUS BONE SCREW
K931665 · HWC
Encore Orthopedics, Inc.
Orthopedic · 318d
Cleared Feb 17, 1994
ALPHATEC COMPRESSION AND RECONSTRUCTION PLATES
K933112 · HRS
Alphatec Mfg., Inc.
Orthopedic · 237d
Cleared Feb 16, 1994
MALLORY-HEAD TOTAL HIP SYSTEM
K921181 · LZO
Biomet, Inc.
Orthopedic · 708d
Cleared Feb 16, 1994
BIMETRIC TOTAL HIP SYSTEM
K921224 · LZO
Biomet, Inc.
Orthopedic · 705d
Cleared Feb 16, 1994
INTEGRAL TOTAL HIP SYSTEM
K921225 · LZO
Biomet, Inc.
Orthopedic · 705d
Cleared Feb 16, 1994
RANAWAT/BURSTEIN TOTAL HIP SYSTEM
K921277 · LPH
Biomet, Inc.
Orthopedic · 701d
Cleared Feb 16, 1994
TAPERLOC FEMORAL STEM AND UNIVERSAL ACETABULAR COM
K921301 · LPH
Biomet, Inc.
Orthopedic · 700d
Cleared Feb 16, 1994
PMI HIP FEMORAL
K923452 · LPH
Biomet, Inc.
Orthopedic · 582d
Cleared Feb 16, 1994
ORTHOLOC ADVANTIM TIBIAL BASE COMPONENT
K932858 · JWH
Dow Corning Wright
Orthopedic · 251d
Cleared Feb 15, 1994
METALLIC TOATAL HIP SYSTEM
K921274 · LPH
Biomet, Inc.
Orthopedic · 700d
Cleared Feb 15, 1994
P.C.A. MODULAR KNEE SYSTEM
K931214 · HSX
Howmedica Corp.
Orthopedic · 342d