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
15481–15504 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Feb 15, 1994
BONE PLATE
K931244 · HRS
Acu Med, Inc.
Orthopedic · 341d
Cleared Feb 14, 1994
STABILITY FEMORAL PROSTHESIS W/HAP
K915655 · MEH
Depuy, Inc.
Orthopedic · 789d
Cleared Feb 14, 1994
ACUFEX ARTHROSCOPE
K934270 · HRX
Acufex Microsurgical, Inc.
Orthopedic · 167d
Cleared Feb 14, 1994
DYONICS DISPOSABLE ARTHROSCOPIC SURGERY BLADES MODIFICATION
K934299 · HRX
Smith & Nephew Dyonics, Inc.
Orthopedic · 165d
Cleared Feb 10, 1994
INSTRUMENT MAKAR PERFIX INTERFERENCE BONE SCREW
K930980 · HWC
Instrument Makar, Inc.
Orthopedic · 350d
Cleared Feb 09, 1994
APR(R) HIP SYST & NATURAL-HIP(R) FOR UNCEMENT USE
K920955 · LPH
Intermedics Orthopedics
Orthopedic · 714d
Cleared Feb 09, 1994
P.F.C. TOTAL HIP SYSTEM POROUS COATED MODULAR ACET
K931189 · LZO
Johnson & Johnson Orthopaedics, Inc.
Orthopedic · 337d
Cleared Feb 07, 1994
IMPLEX ACETABULAR CUP SCREW SYSTEM
K931187 · HWC
Implex Corp.
Orthopedic · 335d
Cleared Feb 01, 1994
TECHMEDICA STANDARD CEMENTED HIP SYSTEM
K926387 · KWY
Techmedica, Inc.
Orthopedic · 406d
Cleared Feb 01, 1994
AME(R) RIGID FIXATION SYSTEM
K930531 · KWP
American Medical Electronics, Inc.
Orthopedic · 364d
Cleared Feb 01, 1994
PUNCH SURGICAL
K933772 · LXH
Mahe-Medizintechnik
Orthopedic · 187d
Cleared Jan 31, 1994
ARTHREX INSTRUMENTS ( HIP )
K926212 · HRX
Arthrex, Inc.
Orthopedic · 417d
Cleared Jan 28, 1994
SERIES 5000 BATTERY POWERED INSTRUMENT SYSTEM
K931395 · KIJ
Micro Surgical Instruments Corp.
Orthopedic · 315d
Cleared Jan 28, 1994
SWISSTEK 2000(TM) CAST REMOVAL SYSTEM
K932653 · LGH
Carapace, Inc.
Orthopedic · 240d
Cleared Jan 28, 1994
SOFAMOR ORTHOPAEDIC INSTRUMENTS
K933242 · LXH
Danek Medical, Inc.
Orthopedic · 210d
Cleared Jan 28, 1994
SNAP BONE REAMER
K935322 · HWE
Surgiquip, Inc.
Orthopedic · 85d
Cleared Jan 27, 1994
UNIVERSAL BONE CEMENT KIT
K931540 · LZN
Biodynamic Technologies, Inc.
Orthopedic · 304d
Cleared Jan 27, 1994
PNEUMATIC WIRE TENSIONER
K934431 · HSZ
Smith & Nephew Richards, Inc.
Orthopedic · 136d
Cleared Jan 27, 1994
SNAP DRILL
K935516 · HWE
Surgiquip, Inc.
Orthopedic · 70d
Cleared Jan 26, 1994
ARTHREX INSTRUMENTS (WRIST)
K926303 · HRX
Arthrex, Inc.
Orthopedic · 407d
Cleared Jan 26, 1994
BONE SAW BLADES
K931176 · HWE
Betzler Mfg., Inc.
Orthopedic · 323d
Cleared Jan 26, 1994
INTERMEDICS ORTHOPEDICS REAMERS
K931733 · HTP
Intermedics Orthopedics
Orthopedic · 294d
Cleared Jan 26, 1994
ACUFLEX DISPOSABLE KNIVES
K933921 · HTS
Acufex Microsurgical, Inc.
Orthopedic · 169d
Cleared Jan 26, 1994
BARRIER BONE WAX APPLICATOR
K934260 · LXH
Phillips Pharmaceuticals, Inc.
Orthopedic · 148d