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
13897–13920 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
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
Cleared Jun 10, 1998
AESCULAP SPINE SYSTEM ADDITIONAL COMPONENTS
K980121 · KWP
Aesculap, Inc.
Orthopedic · 147d
Cleared Jun 10, 1998
ROGACHEFSKY DISTAL RADIUS PLATES
K981283 · HRS
Howmedica, Inc.
Orthopedic · 63d
Cleared Jun 08, 1998
IMPLEX CONTINUUM KNEE SYSTEM: POROUS TIBIAL COMPONENT MODEL NUMBER 05-230 SYSTEM
K981560 · JWH
Implex Corp.
Orthopedic · 38d
Cleared Jun 02, 1998
EXETER INTRAMEDULLARY BONE PLUG
K980843 · JDI
Howmedica, Inc.
Orthopedic · 90d
Cleared Jun 01, 1998
ULTIMAX DISTAL FEMORAL INTRAMEDULLARY ROD SYSTEM
K981230 · HSB
Biodynamic Technologies, Inc.
Orthopedic · 59d
Cleared May 29, 1998
J-FX BIPOLAR HEAD
K980801 · KWY
Johnson & Johnson Professionals, Inc.
Orthopedic · 88d
Cleared May 29, 1998
PEDIATRIC PRC
K981113 · MNH
Acromed Corp.
Orthopedic · 63d
Cleared May 29, 1998
OSTEOLOCK ACETABULAR CUP
K981201 · LZO
Howmedica Corp.
Orthopedic · 57d
Cleared May 27, 1998
OSTEONICS ANTEVERTED NECK HA HIP STEMS
K980766 · MEH
Osteonics Corp.
Orthopedic · 89d