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.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Orthopedic ×
17,816 results
10321–10344 of 17,816
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Dec 08, 2006
ARCOMXL POLYETHYLENE LINERS AND 38/40MM FEMORAL HEADS
K062997 · LZO
Biomet Manufacturing Corp
Orthopedic · 67d
Cleared Dec 07, 2006
ACUMED CONGRUENT BONE PLATE SYSTEM
K063460 · HRS
Acumed, LLC
Orthopedic · 22d
Cleared Dec 06, 2006
TOTAL AND HEMI SHOULDER SYSTEM
K060988 · KWS
Dvo Extremity Solutions, LLC
Orthopedic · 240d
Cleared Dec 06, 2006
DYNASTY ACETABULAR SHELL AND COCR ACETABULAR LINER
K061844 · JDL
Wrightmedicaltechnologyinc
Orthopedic · 160d
Cleared Dec 04, 2006
PREVIEW ANTERIOR CERVICAL PLATE SYSTEM
K062371 · KWQ
Alphaspine, Inc.
Orthopedic · 112d
Cleared Dec 01, 2006
CONSERVE FEMORAL RESURFACING COMPONENT
K062960 · KXA
Wrightmedicaltechnologyinc
Orthopedic · 63d
Cleared Nov 30, 2006
MODIFICATION: TO DEPUY DELTA CERAMIC FEMORAL HEAD
K062748 · LZO
DePuy Orthopaedics, Inc.
Orthopedic · 77d
Cleared Nov 29, 2006
ARTHREX INTERFERENCE SCREW
K062466 · MAI
Arthrex, Inc.
Orthopedic · 97d
Cleared Nov 29, 2006
NOVATION SPLINED RDD FEMORAL STEMS
K063279 · LZO
Exactech, Inc.
Orthopedic · 29d
Cleared Nov 22, 2006
ECLIPSE TOTAL ANKLE IMPLANT
K061749 · HSN
Kinetikos Medical, Inc.
Orthopedic · 154d
Cleared Nov 22, 2006
RADIUS SPINAL SYSTEM
K062270 · NKB
Stryker Spine
Orthopedic · 107d
Cleared Nov 22, 2006
EXCIA TOTAL HIP SYSTEM 36MM CERAMIC HEAD
K062684 · LZO
Aesculap, Inc.
Orthopedic · 75d
Cleared Nov 22, 2006
ADJUST-RIGHT FIXATION DEVICES
K062734 · JDR
Valpo Orthopedic Technology, Inc.
Orthopedic · 70d
Cleared Nov 22, 2006
ACTIVASCREW
K062980 · HWC
Bioretec, Ltd.
Orthopedic · 54d
Cleared Nov 22, 2006
MODIFICATION TO EXPEDIUM SPINE SYSTEM
K063156 · NKB
Depuy Spine, Inc.
Orthopedic · 36d
Cleared Nov 22, 2006
FMP COATED SPIKED ACETABULAR CUP
K063257 · LPH
Encore Medical, L.P.
Orthopedic · 26d
Cleared Nov 22, 2006
PANALOK QUICKANCHOR PLUS, PANALOK RC QUICKANCHOR PLUS DUAL SUTURE, PANALOK...
K063273 · JDR
Depuy Miltek, A Johnson & Johnson Co.
Orthopedic · 23d
Cleared Nov 22, 2006
UNIVERSAL LOCKING SYSTEM, 2.7MM PLATES & SCREWS
K063303 · HRS
Zimmer, Inc.
Orthopedic · 21d
Cleared Nov 17, 2006
APERFIX FEMORAL IMPLANT WITH INSERTER
K062487 · HWC
Cayenne Medical, Inc.
Orthopedic · 84d
Cleared Nov 16, 2006
KINETIC ANTERIOR CERVICAL PLATE
K062643 · KWQ
Life Spine
Orthopedic · 71d
Cleared Nov 16, 2006
SIERRA
K062934 · MNI
Seaspine, Inc.
Orthopedic · 49d
Cleared Nov 15, 2006
MAXIMA ANTERIOR CERVICAL PLATE SYSTEM
K061002 · KWQ
U&I Corp.
Orthopedic · 218d
Cleared Nov 15, 2006
TRIDENT LARGE DIAMETER ACETABULAR INSERTS
K062419 · LPH
Howmedica Osteonics Corp.
Orthopedic · 89d
Cleared Nov 14, 2006
SYNTHES ANTEGRA SYSTEM
K063158 · KWQ
Synthes Spine Co.Lp
Orthopedic · 28d