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
13969–13992 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Oct 29, 1997
KSEA ARTHROPUMP PLUS
K971649 · HRX
KARL STORZ Endoscopy-America, Inc.
Orthopedic · 176d
Cleared Oct 29, 1997
DURATION STABILIZED UHMWPE KNEE COMPONENTS
K972863 · JWH
Howmedica Corp.
Orthopedic · 86d
Cleared Oct 29, 1997
DURATION STABILIZED UHMWPE KNEE COMP., WEAR CLAIMS
K972864 · JWH
Howmedica Corp.
Orthopedic · 86d
Cleared Oct 28, 1997
CSCO FOREHEAD FIXATION SYSTEM
K963502 · MBI
Howmedica Corp.
Orthopedic · 420d
Cleared Oct 27, 1997
COMPRESSION CERCLAGE GUNDOLF CCG-GF
K973098 · JDQ
Plus Orthopedics
Orthopedic · 69d
Cleared Oct 24, 1997
SMC ACETABULAR COMPONENT
K971018 · LPH
Signal Medical Corp.
Orthopedic · 218d
Cleared Oct 24, 1997
TOTAL PERFORMANCE SYSTEM SHAVER
K973195 · HRX
Stryker Endoscopy
Orthopedic · 59d
Cleared Oct 22, 1997
LINK, ACETABULAR REVISION MESH CUP
K972760 · JDJ
Link America, Inc.
Orthopedic · 90d
Cleared Oct 21, 1997
DURACON CONVERSION METAL BACKED PATELLA
K972752 · JWH
Howmedica Corp.
Orthopedic · 90d
Cleared Oct 21, 1997
ADVANCE ULTRA-CONGRUENT TIBIAL INSERT
K972770 · JWH
Wrightmedicaltechnologyinc
Orthopedic · 89d
Cleared Oct 16, 1997
CD SPINAL SYSTEM
K964159 · KWP
Sofamor Danek USA,Inc.
Orthopedic · 365d
Cleared Oct 16, 1997
VARI-ANGLE HIP SCREW (VHS) SYSTEM
K964880 · KTT
Walter Abendschein, M.D.
Orthopedic · 315d
Cleared Oct 16, 1997
SYNTHES SPINE SMALL STATURE ANTERIOR CERVICAL VERTEBRAE PLATE SYSTEM
K971883 · KWQ
Synthes (Usa)
Orthopedic · 147d
Cleared Oct 16, 1997
DURATION STABILIZED UHMWPE ACETABULAR COMPONENTS
K972792 · JDI
Howmedica Corp.
Orthopedic · 80d
Cleared Oct 16, 1997
SYNTHES COMBINATION CLAMP AND DYNAMIZATION CLIP
K973017 · KTT
Synthes (Usa)
Orthopedic · 64d
Cleared Oct 16, 1997
INFINTY DISTAL FEMORAL COMPONENT
K973530 · LPH
Wrightmedicaltechnologyinc
Orthopedic · 28d
Cleared Oct 15, 1997
ZIRCONIA CERAMIC FEMORAL HEAD
K972690 · LZO
Zimmer, Inc.
Orthopedic · 90d
Cleared Oct 15, 1997
ABC TOTAL ELBOW PROTHESIS
K972691 · JDB
Biomet, Inc.
Orthopedic · 90d
Cleared Oct 09, 1997
STRAIGHT-IN BONE SCREW FIXATION SYSTEM
K972622 · MBI
Influence, Inc.
Orthopedic · 87d
Cleared Oct 09, 1997
DEPUY AE TK2 HIP SCREW SYSTEM
K972629 · KTT
Depuy, Inc.
Orthopedic · 87d
Cleared Oct 09, 1997
DUAL OFFSET PERFECTA IMC HIP STEM
K972641 · JDI
Wrightmedicaltechnologyinc
Orthopedic · 86d
Cleared Oct 09, 1997
GAMMA LOCKING NAIL SYSTEM
K972813 · HSB
Howmedica Corp.
Orthopedic · 72d
Cleared Oct 09, 1997
MULTITAK SS SUTURE SYSTEM
K973015 · MBI
Bonutti Research
Orthopedic · 57d
Cleared Oct 06, 1997
HOWMEDICA FULLY THREADED SCREWS
K972811 · HSB
Howmedica Corp.
Orthopedic · 70d