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
14089–14112 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Nov 12, 1997
DEPUY DURALOC ACETABULAR CUP SYSTEM
K972596 · LPH
Depuy, Inc.
Orthopedic · 124d
Cleared Nov 12, 1997
BONE GRAFT HARVESTER
K973560 · HWE
Ds Mfg., Inc.
Orthopedic · 54d
Cleared Nov 10, 1997
FASTERNER, FIXATION, BIODEGRADABLE SOFT TISSUE
K965228 · MAI
United States Surgical, A Division of...
Orthopedic · 314d
Cleared Nov 10, 1997
THE C-FIT & DC-FIT ACETABULAR CUP SYSTEM
K972995 · JDI
Corin USA
Orthopedic · 90d
Cleared Nov 10, 1997
THE CORIFIX LIGAMENT ANCHOR
K973005 · HWC
Corin USA
Orthopedic · 89d
Cleared Nov 10, 1997
MITEK NON ABSORBABLE POLYPROPYLENE H FIX
K973009 · MBI
Mitek Products
Orthopedic · 89d
Cleared Nov 07, 1997
SPINAL CONCEPTS, INC., UNIVERSAL BONE PLATE SYSTEM II
K973586 · HWC
Spinal Concepts, Inc.
Orthopedic · 46d
Cleared Nov 04, 1997
STELKAST BIPOLAR SYSTEM
K972961 · JDI
Stelkast Company
Orthopedic · 85d
Cleared Nov 03, 1997
DEPUY MOTECH PEAK POLYAXIAL ANTERIOR CERVICAL PLATE SYSTEM
K971730 · KWQ
Depuy, Inc.
Orthopedic · 178d
Cleared Nov 03, 1997
PARTNERSHIP REVISION FEMORAL STEMS
K972893 · LZO
Howmedica Corp.
Orthopedic · 90d
Cleared Nov 03, 1997
KERBOULL CROSS
K972928 · JDI
Howmedica, Inc.
Orthopedic · 87d
Cleared Nov 03, 1997
DEPUY MOTECH PROFILE ANTERIOR THORACOLUMBAR PLATE SYSTEM
K973060 · KWQ
Depuy, Inc.
Orthopedic · 77d
Cleared Nov 03, 1997
APR POROUS HA HIP SYSTEM
K973124 · LPH
Sulzer Orthopedics, Inc.
Orthopedic · 75d
Cleared Nov 03, 1997
THE SURGICAL DYNAMICS* S.D. SORB* E-Z TAC*
K973281 · MAI
United States Surgical, A Division of...
Orthopedic · 62d
Cleared Oct 31, 1997
CURVTEK TSR SYSTEM
K972860 · HSZ
Biolectron, Inc.
Orthopedic · 88d
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