FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Orthopedic ×
17,985 results
14113–14136 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
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
Cleared Oct 03, 1997
MAGELLAN MAGNETIC DISTAL TARGETING SYSTEM(PROPOSED NAME), PRODUCT LINE EXTENSION
K971056 · HSB
Wrightmedicaltechnologyinc
Orthopedic · 193d
Cleared Oct 01, 1997
LEIBINGER SELF-DRILLING SCREW
K970912 · HWC
Howmedica Leibinger, Inc.
Orthopedic · 203d
Cleared Oct 01, 1997
DISTALLY FIXED HIP STEM
K971523 · MEH
Sulzer Orthopedics, Inc.
Orthopedic · 156d
Cleared Oct 01, 1997
DEPUY DUPONT ABSORBABLE SET SCREW
K972494 · HWC
Depuy, Inc.
Orthopedic · 90d
Cleared Oct 01, 1997
APOLLO REVISION/CONSTRAINED KNEE SYSTEM
K972501 · JWH
Sulzer Orthopedics, Inc.
Orthopedic · 90d
Cleared Oct 01, 1997
PRECEDENT REVISION HIP SYSTEM
K972637 · LZO
Sulzer Orthopedics, Inc.
Orthopedic · 78d
Cleared Oct 01, 1997
M-2 ANTERIOR PLATE SYSTEM
K972718 · KWQ
Acromed Corp.
Orthopedic · 72d
Cleared Sep 29, 1997
ADVANCE KNEE SYSTEM
K972626 · JWH
Wrightmedicaltechnologyinc
Orthopedic · 77d
Cleared Sep 26, 1997
INNOVASIVE 2.3MM ROC XS SUTURE BONE FASTENER
K972438 · MBI
Innovasive Devices, Inc.
Orthopedic · 88d