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
15193–15216 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
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
Cleared Sep 27, 1994
CONSENSUS KNEE SYSTEM - PRIMARY KNEE
K932837 · JWH
U.S. Medical Products, Inc.
Orthopedic · 473d
Cleared Sep 23, 1994
SURGICAL INSTRUMENTS AND ACCESSORIES
K942956 · HWE
Stryker Corp.
Orthopedic · 92d
Cleared Sep 23, 1994
IMPLEX CEMENT RESTRICTOR SYSTEM
K943378 · LZN
Implex Corp.
Orthopedic · 72d
Cleared Sep 20, 1994
ORTHOSORB(TM) ABSORBABLE CEMENT RESTRICTOR
K932595 · LZN
Johnson & Johnson Orthopaedics, Inc.
Orthopedic · 480d
Cleared Sep 20, 1994
INTEGRITY TOTAL HIP SYSTEM, NON-POROUS
K941486 · JDI
Kirschner Medical Corp.
Orthopedic · 176d
Cleared Sep 20, 1994
P.F.C. CEMENT RESTRICTOR
K942060 · LZN
Johnson & Johnson Professionals, Inc.
Orthopedic · 144d
Cleared Sep 20, 1994
INTEGRAL CO-CR FEMORAL COMPONENT
K942479 · JDG
Biomet, Inc.
Orthopedic · 118d
Cleared Sep 20, 1994
ACETABULAR DOME HOLE PLUGS
K942809 · JDL
Osteonics Corp.
Orthopedic · 98d
Cleared Sep 19, 1994
PIONEER LABORATORIES CABLE PIN
K941174 · HWC
Pioneer Surgical Technology
Orthopedic · 189d
Cleared Sep 19, 1994
IMPACT CO-CR 1-PIECE FEMORAL COMPONENT
K942027 · JDG
Biomet, Inc.
Orthopedic · 146d
Cleared Sep 19, 1994
RX90 FEMORAL COMPONENT
K942028 · JDG
Biomet, Inc.
Orthopedic · 146d
Cleared Sep 16, 1994
ARTHRO-FLO IRRIGATION SYSTEM MODIFICATION
K935617 · HRX
Davol Inc., Sub. C. R. Bard, Inc.
Orthopedic · 298d
Cleared Sep 16, 1994
INNOVASIVE ARTHROSCOPIC ROC SUTURE BONE FASTENER
K941273 · HRX
Innovasive Devices, Inc.
Orthopedic · 184d
Cleared Sep 12, 1994
TITAN TROCHANTERO-DIAHYSEAL TOTAL HIP PROSTHESIS
K933108 · LZO
Landos, Inc.
Orthopedic · 444d
Cleared Sep 12, 1994
HAIG NAIL
K940736 · JDS
Howmedica Corp.
Orthopedic · 207d