Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

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

Filters: Orthopedic ×
17,985 results
16585–16608 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Oct 10, 1989
CROSS ROUND & SQUARE SPINAL RODS & DIST. SPINAL
K894472 · KWP
Buckman Co., Inc.
Orthopedic · 84d
Cleared Oct 10, 1989
PT DISTAL TIP CEMENT SPACER
K894708 · JDK
Osteonics Corp.
Orthopedic · 78d
Cleared Oct 06, 1989
INTERMEDICS HIGH TIBIAL OSTEOTOMY SYSTEM
K892228 · HRS
Intermedics Orthopedics
Orthopedic · 184d
Cleared Oct 06, 1989
MITEK ANCHOR DRILL
K892903 · HTW
Mitek Surgical Products, Inc.
Orthopedic · 169d
Cleared Oct 06, 1989
SECOND GENERATION KNEE SYSTEM
K894334 · JWH
Orthomet, Inc.
Orthopedic · 84d
Cleared Sep 29, 1989
MODIFIED GLENOID ARCUATE DRILL & DISP. FLEXI-BITS
K885229 · HSZ
Romano Surgical Instrumentation, Inc.
Orthopedic · 294d
Cleared Sep 28, 1989
ACL DRILL GUIDE SYSTEM
K892655 · LXI
Baxter Healthcare Corp
Orthopedic · 168d
Cleared Sep 28, 1989
MITEK DRILL GUIDE
K892904 · HXY
Mitek Surgical Products, Inc.
Orthopedic · 161d
Cleared Sep 27, 1989
MODIFIED GEMINI ACETABULAR CUP
K894298 · JDI
Depuy, Inc.
Orthopedic · 97d
Cleared Sep 26, 1989
CERAMIC FEMORAL HEAD
K893685 · LZO
Dow Corning Wright
Orthopedic · 133d
Cleared Sep 19, 1989
MITEK ANCHOR
K892126 · JDR
Mitek Surgical Products, Inc.
Orthopedic · 173d
Cleared Sep 15, 1989
PLUS TOTAL KNEE SYSTEM, (PPD) TIBIAL COMPONENT
K893762 · JWH
Orthomet, Inc.
Orthopedic · 119d
Cleared Sep 15, 1989
HALL VERSIPOWER SURGICAL INSTRUMENT SYSTEM
K895198 · HWE
Zimmer, Inc.
Orthopedic · 35d
Cleared Sep 14, 1989
MOD. FEMORAL COM. & CLUSTER PATTER OUTER SHELL
K894149 · JDI
Howmedica Corp.
Orthopedic · 92d
Cleared Sep 13, 1989
ACE BEADED K-WIRES ACE OLIVE WIRES
K895079 · HTY
Buckman Co., Inc.
Orthopedic · 30d
Cleared Sep 12, 1989
KRONNER SACRAL PIN GUIDE
K895172 · LXH
Kronner Medical
Orthopedic · 33d
Cleared Sep 12, 1989
SKELETAL FIXATION PIN
K895173 · JDW
Kronner Medical
Orthopedic · 33d
Cleared Sep 12, 1989
CORTICAL SCREW
K895217 · HWC
Orthopedic Systems, Inc.
Orthopedic · 25d
Cleared Sep 12, 1989
CANCELLOUS SCREW SHORT THREAD DIAMETER 6.5MM
K895218 · HWC
Orthopedic Systems, Inc.
Orthopedic · 25d
Cleared Sep 12, 1989
CANCELLOUS SCREW LONG THREAD DIAMETER 6.5MM
K895219 · HWC
Orthopedic Systems, Inc.
Orthopedic · 25d
Cleared Sep 11, 1989
P.F.C. HIP SYSTEM POROUS COATED FEMORAL COMPONENT
K893872 · KWY
Johnson & Johnson Professionals, Inc.
Orthopedic · 108d
Cleared Sep 11, 1989
OMNIFIT SELF TAPPING CANCELLOUS BONE SCREWS
K894124 · HWC
Osteonics Corp.
Orthopedic · 91d
Cleared Sep 11, 1989
ACE ORTHOPAEDIC WASHERS
K895107 · HTN
Buckman Co., Inc.
Orthopedic · 27d
Cleared Sep 11, 1989
INTERMEDICS POWER BROACH IMPACTOR
K895121 · HSZ
Intermedics Orthopedics
Orthopedic · 27d