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
14929–14952 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared May 25, 1995
DEPUY CDH PROSTHESIS
K945844 · MEH
Depuy, Inc.
Orthopedic · 176d
Cleared May 25, 1995
METAL BACKED ACETABULAR COMPONENT
K950542 · JDL
Encore Orthopedics, Inc.
Orthopedic · 107d
Cleared May 25, 1995
LINK SADDLE PROTHESIS
K951355 · KWL
Turnkey Intergration USA, Inc.
Orthopedic · 78d
Cleared May 23, 1995
ARTHROSCOPE FOR SMALL JOINT AFTER FELDKAMP, MODEL 8871.011
K940179 · HRX
Richard Wolf Medical Instruments Corp.
Orthopedic · 496d
Cleared May 23, 1995
OPTUS ARTHROSCOPES AND MINI-ARTHROSCOPES
K945267 · HRX
Optus, Inc.
Orthopedic · 207d
Cleared May 23, 1995
CMF-TITANIUM CRANIO-MAXILLO-FACIAL FRACTURE FIXATION (OSTEOSYNTHESIS) SYSTEM
K946165 · HRS
Elekta Instruments, Inc.
Orthopedic · 155d
Cleared May 22, 1995
FIXANO TOTAL TRAPEZIO METACARPAL PROSTHESIS, 2ND
K931265 · JWI
Ferguson Medical
Orthopedic · 805d
Cleared May 22, 1995
INSALL-BURSTEIN II
K935080 · JWH
Hospital For Special Surgery
Orthopedic · 574d
Cleared May 22, 1995
SELECT(R) SHOULDER ALL POLY GLENOID
K935802 · KWS
Intermedics Orthopedics
Orthopedic · 536d
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