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
16105–16128 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Apr 02, 1991
AUTOGENESIS(TM) AUTOMATOR
K905514 · KTT
Advanced Biosearch Assn.
Orthopedic · 116d
Cleared Apr 01, 1991
KINEMAX SUPERSTABILIZER TOTAL KNEE SYSTEM
K904208 · JWH
Howmedica Corp.
Orthopedic · 201d
Cleared Apr 01, 1991
AMSET PLD SYSTEM
K905014 · HRX
Advanced Med/Surg, Inc.
Orthopedic · 146d
Cleared Apr 01, 1991
OMNIFIT TOTAL KNEE BONE AUGMENTATION WEDGES
K910083 · HSX
Osteonics Corp.
Orthopedic · 83d
Cleared Mar 27, 1991
ORTHOCONCEPT ARTHROSCOPIC PUMP
K910164 · HRX
Orthoconcept, Inc.
Orthopedic · 71d
Cleared Mar 26, 1991
ARTHRO-FMS-3/IRRIGATION SETS (VARIOUS)
K905785 · HRX
Orthoconcept, Inc.
Orthopedic · 97d
Cleared Mar 26, 1991
GLOBAL TOTAL SHOULDER
K905786 · KWT
Depuy, Inc.
Orthopedic · 89d
Cleared Mar 26, 1991
PREMIER-TOTAL(TM) HIP WITH CALCITITE(R) COATING
K910755 · MEH
Intermedics Orthopedics
Orthopedic · 39d
Cleared Mar 26, 1991
OSTEONICS ION IMPLANTED FEMORAL BEARING SERIES
K910988 · JDI
Osteonics Corp.
Orthopedic · 19d
Cleared Mar 21, 1991
ISOLA SLOTTED CONNECT/ANGLED SLOTTED CONNECTOR
K905826 · KWP
Acromed Corp.
Orthopedic · 80d
Cleared Mar 15, 1991
MOTOR DRIVEN EXTIRPATION INSTRUMENTS
K904859 · HRX
Aesculap, Inc.
Orthopedic · 137d
Cleared Mar 14, 1991
HOWMEDICA HNR SYSTEM
K903563 · LWJ
Howmedica Corp.
Orthopedic · 219d
Cleared Mar 14, 1991
ACE RECONSTRUCTIVE PLATE
K905595 · HRS
Ace Medical Co.
Orthopedic · 91d
Cleared Mar 12, 1991
EXACTECH HUMERAL SHOULDER PROSTHESIS
K905577 · HSD
Exactech, Inc.
Orthopedic · 90d
Cleared Mar 12, 1991
TOTAL SHOULDER PROSTHESIS POLYETHYLENE GLENOIND CO
K905580 · HSD
Exactech, Inc.
Orthopedic · 90d
Cleared Mar 12, 1991
Q SYSTEM 28 HIP STEM
K910010 · LWJ
Turnkey Intergration USA, Inc.
Orthopedic · 69d
Cleared Mar 12, 1991
BIODEGRADABLE SURGICAL STAPLE
K910723 · JDR
Instrument Makar, Inc.
Orthopedic · 20d
Cleared Mar 07, 1991
ZIMMER CERAMIC FEMORAL HEADS
K905739 · LZO
Zimmer, Inc.
Orthopedic · 73d
Cleared Mar 05, 1991
ALTA(R) PFX IM ROD
K903526 · HSB
Howmedica Corp.
Orthopedic · 211d
Cleared Mar 05, 1991
SYSTEM TEN, MODEL 100 SURGERY SYST/ORTHOPAEDIC USE
K905451 · JDX
Advanced Osseous Technologies
Orthopedic · 90d
Cleared Mar 05, 1991
THE UNIVERSAL CEMENT PLUG(TM)
K910135 · LZN
Biotron , Ltd.
Orthopedic · 55d
Cleared Mar 05, 1991
ARTIFLEX(TM)
K910274 · LGF
Beiersdorf, Inc.
Orthopedic · 41d
Cleared Mar 04, 1991
APR AND APR II PRESS-FIT UNIVERSAL HIP SYSTEM
K905781 · MEH
Intermedics Orthopedics
Orthopedic · 66d
Cleared Mar 01, 1991
NEXUS ACETABULAR CUP
K905408 · JDI
Dow Corning Wright
Orthopedic · 88d