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
13753–13776 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jul 13, 1998
LM ANCHOR
K981755 · MBI
Li Medical Technologies, Inc.
Orthopedic · 56d
Cleared Jul 13, 1998
LM ANCHOR
K981764 · MBI
Li Medical Technologies, Inc.
Orthopedic · 55d
Cleared Jul 13, 1998
LORENZ PECTUS SUPPORT BAR STABILIZER
K981789 · HRS
Walter Lorenz Surgical, Inc.
Orthopedic · 54d
Cleared Jul 13, 1998
LACTOSORB POP RIVET
K981798 · JDR
Biomet, Inc.
Orthopedic · 53d
Cleared Jul 13, 1998
MODIFICATION OF TOWNLEY PEDICLE SCREW PLATING SYSTEM
K982154 · MNI
Danek Medical, Inc.
Orthopedic · 24d
Cleared Jul 09, 1998
TITANIUM INTRAMEDULLARY NAIL, TITANIUM LOCKING SCREW
K981529 · JDS
Smith & Nephew, Inc.
Orthopedic · 71d
Cleared Jul 09, 1998
OSTEONICS OMNIFIT HA HIP STEM SERIES, OSTEONICS SECUR-FIT HA HIP STEM SERIES,...
K982032 · MEH
Osteonics Corp.
Orthopedic · 29d
Cleared Jul 08, 1998
EBI DFS JOINT FIXATOR, MODEL 02800
K981483 · KTT
Electro-Biology, Inc.
Orthopedic · 75d
Cleared Jul 02, 1998
KYPHON INFLATABLE BONE TAMP
K981251 · HRX
Kyphon, Inc.
Orthopedic · 87d
Cleared Jul 01, 1998
ACL AVULSION LAG SCREW WITH SHEATH MODEL NUMBER AR-6001
K981187 · HWC
Arthrex, Inc.
Orthopedic · 90d
Cleared Jun 30, 1998
FUTURA BIOMEDICAL FLEXIBLE GREAT TOE IMPLANT
K981194 · KWH
Nexa Orthopedics, Inc.
Orthopedic · 89d
Cleared Jun 30, 1998
TIMX LOW BACK SYSTEM TITANIUM MX ROD BASED LOW BACK SYSTEM
K981714 · MNH
Acromed Corp.
Orthopedic · 46d
Cleared Jun 26, 1998
RELIANCE LONG STEM FEMORAL COMPONENTS
K980813 · JDI
Howmedica, Inc.
Orthopedic · 115d
Cleared Jun 25, 1998
CROSS MEDICAL BONE PLATE SYSTEM/ CM BONE PLATE SYSTEM/CROSS TI BONE PLATE SYSTEM
K961320 · HWC
Buckman Co., Inc.
Orthopedic · 811d
Cleared Jun 25, 1998
SMC 28MM CERAMIC FEMORAL HEADS
K981302 · LZO
Signal Medical Corp.
Orthopedic · 77d
Cleared Jun 24, 1998
UNIVERSAL DRIVE SYSTEM
K981269 · HRX
Linvatec Corp.
Orthopedic · 78d
Cleared Jun 22, 1998
HOWMEDICA SCN NAIL
K981261 · HSB
Howmedica Corp.
Orthopedic · 76d
Cleared Jun 22, 1998
OSTEO I-C HUMERAL NAIL SYSTEM
K981309 · HSB
Osteonics Corp.
Orthopedic · 73d
Cleared Jun 22, 1998
INNOVASIVE DEVICES MENISCAL DART REPAIR SYSTEM
K981340 · MAI
Innovasive Devices, Inc.
Orthopedic · 70d
Cleared Jun 22, 1998
DEPUY PROFILE ROUND HEAD INTERFERENCE SCREW AND DEPUY PHANTOM RESORBABLE...
K981670 · HWC
Depuy, Inc.
Orthopedic · 41d
Cleared Jun 18, 1998
DURACON(R) SMALL STABILIZER TIBIAL INSERT
K974843 · JWH
Howmedica Corp.
Orthopedic · 176d
Cleared Jun 17, 1998
BLACKSTONE MEDICAL INC. ANTERIOR CERVICAL PLATE SYSTEM
K974885 · KWQ
Blackstone Medical, Inc.
Orthopedic · 169d
Cleared Jun 16, 1998
INNOVASIVE 3.5MM METAL ROC XS SUTURE BONE FASTENER
K981193 · MBI
Innovasive Devices, Inc.
Orthopedic · 75d
Cleared Jun 10, 1998
ARTHREX PUDDU OSTEOTOMY SYSTEM
K973812 · HRS
Arthrex, Inc.
Orthopedic · 246d