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
11089–11112 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared May 12, 2005
ACUMED SCAPULA CONGRUENT BONE PLATE SYSTEM
K051083 · HRS
Acumed, LLC
Orthopedic · 15d
Cleared May 11, 2005
RADIOPAQUE BONE CEMENT
K043518 · NDN
Cardinalhealth
Orthopedic · 142d
Cleared May 11, 2005
ALUMINA HEAD
K050556 · LZO
Fournitures Hospitalieres Industrie
Orthopedic · 69d
Cleared May 11, 2005
HALLMARKTM ANTERIOR CERVICAL PLATE SYSTEM
K050892 · KWQ
Blackstone Medical, Inc.
Orthopedic · 33d
Cleared May 11, 2005
TRABECULAR METAL ACETABULAR REVISION SHELLS
K050937 · LPH
Zimmer Trabecular
Orthopedic · 27d
Cleared May 04, 2005
PROCOTYL-E ACETABULAR SYSTEM
K043073 · KWA
Wrightmedicaltechnologyinc
Orthopedic · 177d
Cleared May 04, 2005
LAGUNA PEDICLE SCREW SYSTEM
K050060 · MNI
Allez Spine, LLC
Orthopedic · 113d
Cleared May 04, 2005
BASIS SPINAL SYSTEM
K050484 · KWP
Medtronic Sofamor Danek, Inc.
Orthopedic · 68d
Cleared May 04, 2005
ABC 2 SCREW
K050813 · KWQ
Aesculap, Inc.
Orthopedic · 34d
Cleared May 04, 2005
HA COATED LAG SCREW
K050849 · KTT
Smith & Nephew, Inc.
Orthopedic · 30d
Cleared May 04, 2005
KNEE FUSION NAIL
K050938 · JDS
Smith & Nephew, Inc.
Orthopedic · 20d
Cleared May 03, 2005
MODIFICATION TO MBCP
K043005 · MQV
Biomatlante
Orthopedic · 183d
Cleared Apr 28, 2005
RX90 LOW PROFILE ACETABULAR SYSTEM
K042989 · LPH
Biomet, Inc.
Orthopedic · 181d
Cleared Apr 27, 2005
SYNTHES (USA) 3.5MM CONICAL SCREWS
K050683 · HWC
Synthes (Usa)
Orthopedic · 41d
Cleared Apr 26, 2005
SBI HAND FIXATION SYSTEM (TM)
K050462 · HRS
Small Bone Innovations, LLC
Orthopedic · 62d
Cleared Apr 26, 2005
SYNTHES (USA) 3.5/4.5MM LCP MEDIAL PROXIMAL TIBIA PLATES
K050646 · HRS
Synthes (Usa)
Orthopedic · 43d
Cleared Apr 26, 2005
DISTAL VOLAR RADIUS ANATOMICAL PLATE SYSTEM
K050932 · LXT
Hand Innovations, Inc.
Orthopedic · 12d
Cleared Apr 21, 2005
CAMCERAM TCP
K050357 · MQV
Cam Implants B.V.
Orthopedic · 66d
Cleared Apr 21, 2005
VERTEVIEW ANTERIOR CERVICAL PLATE SYSTEM
K050588 · KWQ
Innovative Spinal Design, LLC
Orthopedic · 44d
Cleared Apr 21, 2005
SYNTHES 3.0MM HEADLESS COMPRESSION SCREWS
K050636 · HWC
Synthes (Usa)
Orthopedic · 41d
Cleared Apr 20, 2005
SMITH & NEPHEW INTELIJET FLUID MANAGEMENT SYSTEMS
K050580 · HRX
Smith & Nephew Endoscopy, Inc.
Orthopedic · 44d
Cleared Apr 20, 2005
MG II TOTAL KNEE SYSTEM STEMMED TIBIAL BASEPLATE COMPONENTS
K050723 · JWH
Zimmer, Inc.
Orthopedic · 30d
Cleared Apr 18, 2005
ADVANCE HA COATED SPIKED TIBIAL BASE AND ADVANCE HA COATED MODULAR KEEL
K043083 · MBH
Wrightmedicaltechnologyinc
Orthopedic · 161d
Cleared Apr 18, 2005
REFIX PIN (PLLA), MODELS 2070L, 2770L, 3570L, 4570L
K043339 · HTY
Xtremi-T, LLC
Orthopedic · 136d