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
15601–15624 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
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
Cleared Feb 15, 1994
BONE PLATE
K931244 · HRS
Acu Med, Inc.
Orthopedic · 341d
Cleared Feb 14, 1994
STABILITY FEMORAL PROSTHESIS W/HAP
K915655 · MEH
Depuy, Inc.
Orthopedic · 789d
Cleared Feb 14, 1994
ACUFEX ARTHROSCOPE
K934270 · HRX
Acufex Microsurgical, Inc.
Orthopedic · 167d
Cleared Feb 14, 1994
DYONICS DISPOSABLE ARTHROSCOPIC SURGERY BLADES MODIFICATION
K934299 · HRX
Smith & Nephew Dyonics, Inc.
Orthopedic · 165d
Cleared Feb 10, 1994
INSTRUMENT MAKAR PERFIX INTERFERENCE BONE SCREW
K930980 · HWC
Instrument Makar, Inc.
Orthopedic · 350d
Cleared Feb 09, 1994
APR(R) HIP SYST & NATURAL-HIP(R) FOR UNCEMENT USE
K920955 · LPH
Intermedics Orthopedics
Orthopedic · 714d
Cleared Feb 09, 1994
P.F.C. TOTAL HIP SYSTEM POROUS COATED MODULAR ACET
K931189 · LZO
Johnson & Johnson Orthopaedics, Inc.
Orthopedic · 337d
Cleared Feb 07, 1994
IMPLEX ACETABULAR CUP SCREW SYSTEM
K931187 · HWC
Implex Corp.
Orthopedic · 335d
Cleared Feb 01, 1994
TECHMEDICA STANDARD CEMENTED HIP SYSTEM
K926387 · KWY
Techmedica, Inc.
Orthopedic · 406d