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
15745–15768 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Nov 24, 1992
S-ROM TOTAL HIP REPLACEMENT SYSTEM
K920739 · JDI
Joint Medical Products Corp.
Orthopedic · 279d
Cleared Nov 24, 1992
ULTIMA ALL UHMWPE CEMENTED ACETABULAR CUPS
K924115 · JDI
Johnson & Johnson Orthopaedics, Inc.
Orthopedic · 102d
Cleared Nov 24, 1992
POLY-DIAL INSERTS
K924492 · LPH
Joint Medical Products Corp.
Orthopedic · 82d
Cleared Nov 24, 1992
TRUE/ FLEX FIBULA RODS
K924656 · HSB
Applied Osteo Systems, Inc.
Orthopedic · 70d
Cleared Nov 24, 1992
TRUE/FLEX METATARSAL RODS
K924657 · KTW
Applied Osteo Systems, Inc.
Orthopedic · 70d
Cleared Nov 23, 1992
SEIDEL HUMERAL LOCKING NAIL -- ADDITIONAL LENGTHS
K924004 · JDS
Howmedica Corp.
Orthopedic · 105d
Cleared Nov 20, 1992
FX-CABLELOK SYSTEM
K922142 · JDQ
Bio-Tech Co.
Orthopedic · 198d
Cleared Nov 16, 1992
MODIFIED TSRH CENTRAL POST HOOKS
K922520 · KWP
Sofamor Danek Mfg., Inc.
Orthopedic · 178d
Cleared Nov 09, 1992
P.F.C. MODULAR TOTAL KNEE SYSTEM, MODULAR PLUS
K923807 · JWH
Johnson & Johnson International
Orthopedic · 103d
Cleared Nov 06, 1992
PERFECTA TOTAL HIP SYSTEM, CERAMIC FEMORAL HEAD
K921836 · LZO
Orthomet, Inc.
Orthopedic · 203d
Cleared Nov 06, 1992
ANTERIOR CERVICAL PLATE SYSTEM
K922087 · KWQ
Sofamor Danek Mfg., Inc.
Orthopedic · 186d
Cleared Nov 06, 1992
BENDEREV DRILL GUIDE
K923776 · HXY
Neimark Labs, Inc.
Orthopedic · 101d
Cleared Nov 04, 1992
ZIRCONIA CERAMIC MODULAR HEAD 9TYPE II TAPER
K915641 · LZO
Biomet, Inc.
Orthopedic · 323d
Cleared Nov 04, 1992
C-FIT CEMENTED HIP STEM
K923898 · JDI
Turnkey Intergration USA, Inc.
Orthopedic · 92d
Cleared Nov 04, 1992
CEMENT RESTRICTOR FOR PROFORMA AND PERFECTA TOTAL
K923909 · LZN
Orthomet, Inc.
Orthopedic · 92d
Cleared Nov 03, 1992
KINAMED 32MM BIOCERAM-Z TOATAL HIP FEMORAL BALL
K920290 · LZO
Kinamed, Inc.
Orthopedic · 286d
Cleared Oct 30, 1992
KINAMED 26MM BIOCERAN-Z TOTAL HIP FEMORAL BALL
K920219 · LZO
Kinamed, Inc.
Orthopedic · 288d
Cleared Oct 30, 1992
OMNIFLEX-C UHMWPE MID-SHAFT RESTRICTOR
K923616 · JDK
Osteonics Corp.
Orthopedic · 101d
Cleared Oct 27, 1992
TSRH L CONNECTOR -- MODIFICATION
K923339 · KWP
Sofamor Danek Mfg., Inc.
Orthopedic · 125d
Cleared Oct 27, 1992
QUICKANCHOR
K924665 · JDR
Mitek Surgical Products, Inc.
Orthopedic · 47d
Cleared Oct 23, 1992
LUNDEEN SUBTALAR PEG IMPLANT
K922292 · MJW
Sgarlato Laboratories, Inc.
Orthopedic · 161d
Cleared Oct 22, 1992
MITEK BONE ANCHOR, MODIFICATION
K915889 · JDR
Mitek Surgical Products, Inc.
Orthopedic · 307d
Cleared Oct 22, 1992
S-ROM ZIRCONIA CERMAMIC FEMORAL HEAD
K921111 · LZO
Joint Medical Products Corp.
Orthopedic · 227d
Cleared Oct 20, 1992
OSTEONICS ZIRCONIA C-TAPER FEMORAL BEARING HEAD
K915396 · LZO
Osteonics Corp.
Orthopedic · 326d