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
12673–12696 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Sep 06, 2001
MODIFICATION TO THE I.C.O.S SCREW
K011821 · HWC
New Deal, S.A.
Orthopedic · 87d
Cleared Sep 06, 2001
MODIFICATION TO THE TAC' PIN
K011875 · JDW
New Deal, S.A.
Orthopedic · 83d
Cleared Sep 05, 2001
R120 MODULAR TOTAL HIP SYSTEM
K011774 · JDI
Osteoimplant Technology, Inc.
Orthopedic · 90d
Cleared Aug 31, 2001
MODEL 2000 AXYALOOP SELF-TAPPING BONE ANCHOR, MODEL 2000
K011912 · MBI
Axya Medical, Inc.
Orthopedic · 73d
Cleared Aug 31, 2001
STRYKER PLATING SYSTEM BASIC FRAGMENT SET
K012162 · HRS
Howmedica Osteonics Corp.
Orthopedic · 51d
Cleared Aug 30, 2001
THE UNI-CLIP STAPLE
K011716 · JDR
New Deal, S.A.
Orthopedic · 87d
Cleared Aug 30, 2001
THE TRABECULAR METAL TECHNOLOGY ACETABULAR AUGMENT SYSTEM, MODELS 4893-XX-YY...
K012507 · LPH
Implex Corp.
Orthopedic · 24d
Cleared Aug 29, 2001
VULCAN TAC PROBES, MODEL 911XXX
K003198 · HRX
Oratec Interventions, Inc.
Orthopedic · 321d
Cleared Aug 29, 2001
ACUMATCH C-SERIES CEMENTED FEMORAL COMPONENT, MODEL SIZE 0
K012493 · JDI
Exactech, Inc.
Orthopedic · 26d
Cleared Aug 27, 2001
MACROPORE IB RESORBABLE PLUG
K011715 · JDI
Macropore Biosurgery, Inc.
Orthopedic · 84d
Cleared Aug 24, 2001
THE SPIN SNAP-OFF SCREW
K011946 · HWC
New Deal, S.A.
Orthopedic · 64d
Cleared Aug 24, 2001
FLEX-NAILS
K012161 · HTY
Fixano SA
Orthopedic · 44d
Cleared Aug 22, 2001
MODIFICATION TO: TRINICA ANTERIOR CERVICAL PLATE SYSTEM
K012305 · KWQ
Sulzer Spine-Tech
Orthopedic · 30d
Cleared Aug 20, 2001
INTERLOK / HA COPELAND RESURFACING HEADS
K010635 · MBF
Biomet, Inc.
Orthopedic · 171d
Cleared Aug 17, 2001
TITANIUM COMPRESSION ANCHOR SYSTEM MODEL VERSION 2
K012280 · HWC
Triage Medical, Inc.
Orthopedic · 29d
Cleared Aug 15, 2001
VHS PEDIATRIC HIP SCREW SYSTEM
K011603 · KTT
Walter Abendschein, M.D.
Orthopedic · 83d
Cleared Aug 15, 2001
MODIFICATION TO AEQUALIS SHOULDER SYSTEM
K012212 · KWS
Tornier
Orthopedic · 30d
Cleared Aug 15, 2001
SPIRAL RADIUS 90-D SST SYSTEM
K012273 · MNH
United States Surgical, A Division of...
Orthopedic · 27d
Cleared Aug 15, 2001
MAXIM RPG PS FEMORAL COMPONENT
K012348 · JWH
Biomet, Inc.
Orthopedic · 22d
Cleared Aug 14, 2001
BAUMER LOCKING NAIL
K011504 · JDS
Baumer, S.A
Orthopedic · 90d
Cleared Aug 09, 2001
SYNTHES LCP PROXIMAL TIBIA PLATE
K011978 · HRS
Synthes (Usa)
Orthopedic · 45d
Cleared Aug 07, 2001
WUJIN #3 FEMORAL BONE PLATE
K011459 · HRS
Biopro, Inc.
Orthopedic · 88d
Cleared Aug 07, 2001
WUJIN #3 TIBIAL BONE PLATE
K011460 · HRS
Biopro, Inc.
Orthopedic · 88d
Cleared Aug 07, 2001
SCS CLARIS SPINAL SCREWS, TYPES V,G,E
K011807 · MNI
Ortho Tec, LLC
Orthopedic · 57d