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
15073–15096 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared May 22, 1995
NATURAL-KNEE II SYSTEM
K936159 · JWH
Intermedics Orthopedics
Orthopedic · 515d
Cleared May 22, 1995
MITEK TOGGLE ANCHOR(TM)
K950070 · JDR
Mitek Surgical Products, Inc.
Orthopedic · 133d
Cleared May 22, 1995
SYNTHES(USA) SYNTHES HYBRID EXTERNAL FIXATOR
K950384 · LXT
Synthes (Usa)
Orthopedic · 110d
Cleared May 22, 1995
HEMI-SHOULDER PROSTHESIS
K950594 · HSD
Encore Orthopedics, Inc.
Orthopedic · 102d
Cleared May 22, 1995
PROFORM CEMENTED FEMORAL COMPONENT
K951083 · JDG
Stelkast Company
Orthopedic · 74d
Cleared May 19, 1995
TIBIA-TALUS-CALCANEUS NAIL
K950394 · HSB
Smith & Nephew Richards, Inc.
Orthopedic · 107d
Cleared May 17, 1995
ALL POLYETHYLENE CEMENTED ACETABULAR CUP
K943696 · JDI
Depuy, Inc.
Orthopedic · 292d
Cleared May 17, 1995
PRECISION OSTEOLOCK FEMORAL COMPONENT
K944592 · LPH
Howmedica Corp.
Orthopedic · 240d
Cleared May 17, 1995
MED-SURG SUTURE WASHER
K950250 · HWC
Medical Surgical, Inc.
Orthopedic · 114d
Cleared May 17, 1995
ALPHA SYSTEM
K950312 · JDI
Zimmer, Inc.
Orthopedic · 111d
Cleared May 17, 1995
SYSTEM 2000 REPLACEMENT BATTERY, SYSTEM 2000-EXTENDED RUN REPLACEMENT BATTERY
K951450 · KIJ
Strenumed, Inc.
Orthopedic · 49d
Cleared May 16, 1995
EXETER INTRAMEDULLARY BONE PLUG
K933077 · LZN
Howmedica Corp.
Orthopedic · 692d
Cleared May 16, 1995
ORTHOMET ACETABULAR ROOF REINFORCEMENT RING
K944856 · HRS
Wrightmedicaltechnologyinc
Orthopedic · 225d
Cleared May 16, 1995
HOWMEDICE BONE PLUG
K951860 · LZN
Howmedica Corp.
Orthopedic · 25d
Cleared May 16, 1995
PFC CEMENT RESTRICTOR
K951934 · LZN
Johnson & Johnson Professionals, Inc.
Orthopedic · 21d
Cleared May 15, 1995
APOFIX CERVICAL SPINE FIXATION
K945022 · KWP
Sofamor Co.
Orthopedic · 214d
Cleared May 15, 1995
CROSS PIN SCREW SYSTEM
K946228 · JDW
Depuy, Inc.
Orthopedic · 144d
Cleared May 15, 1995
DARWIN KNEE SYSTEM (CRUCIATE SUBSTITUTING) POROUS COATED AND NON-POROUS COATED
K950010 · JWH
Johnson & Johnson Professionals, Inc.
Orthopedic · 132d
Cleared May 15, 1995
RINGLOC CONSTRAINED LINER
K950202 · KWZ
Biomet, Inc.
Orthopedic · 117d
Cleared May 15, 1995
ARGUS ARTHROSCOPY INSTRUMENT SYSTEM
K950242 · HRX
Argus Medical Co., Inc.
Orthopedic · 115d
Cleared May 12, 1995
DANEK RIGID ARTHROSCOPE
K950501 · HRX
Sofamor Danek USA,Inc.
Orthopedic · 95d
Cleared May 12, 1995
KSEA DISPOSABLE TUBING SET FOR THE ARTHROPUMP
K950561 · HRX
KARL STORZ Endoscopy-America, Inc.
Orthopedic · 93d
Cleared May 11, 1995
BIOSTOP G BONE CEMENT RESTRICTOR
K943727 · LZN
Landos, Inc.
Orthopedic · 282d
Cleared May 11, 1995
ETHICON DRILL BIT AND DRILL GUIDE
K944590 · HSZ
Ethicon, Inc.
Orthopedic · 234d