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
15529–15552 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jan 07, 1994
ES-100 ACCESSORIES
K932261 · HWE
Elekta Instruments, Inc.
Orthopedic · 262d
Cleared Jan 07, 1994
3M MAXI-DRIVER II DBATTERY POWERED SYSTEM
K932307 · KIJ
3M Health Care, Ltd.
Orthopedic · 241d
Cleared Jan 05, 1994
KINETIK GREAT TOE SYSTEM
K924724 · LZJ
Kinetikos Medical, Inc.
Orthopedic · 471d
Cleared Jan 05, 1994
PRISM BONE CEMENT MIXING SYSTEM
K925025 · JDZ
Depuy, Inc.
Orthopedic · 460d
Cleared Dec 30, 1993
PHOENIX BONE SCREWS PBS-TYPE SERIES
K930125 · HXA
Phoenix Bioengineering, Inc.
Orthopedic · 352d
Cleared Dec 15, 1993
CARAPACE STERILE CAST PADDING
K931672 · LGF
Carapace, Inc.
Orthopedic · 253d
Cleared Dec 08, 1993
MITEK SUPER QUICKANCHOR, MODIFICATION
K930893 · JDR
Mitek Surgical Products, Inc.
Orthopedic · 313d
Cleared Dec 06, 1993
SYMBIOSIS REUSABLE ARTHROSCOPIC SURGICAL INST.
K924016 · HRX
Symbiosis Corp.
Orthopedic · 482d
Cleared Nov 30, 1993
OSTEONICS UNIX UNICOMPARTMENTAL
K923011 · HRY
Osteonics Corp.
Orthopedic · 526d
Cleared Nov 30, 1993
ORTHOPAEDIC POLYETHYLENE CABLE
K924141 · JDQ
Smith & Nephew Richards, Inc.
Orthopedic · 469d
Cleared Nov 30, 1993
ORTHOLOC ADVANTIM TIBIAL STEM 5 DEGREE
K930228 · JWH
Dow Corning Wright
Orthopedic · 315d
Cleared Nov 17, 1993
APR FEMORAL HIP COMPONENT
K930812 · JDI
Intermedics Orthopedics
Orthopedic · 273d
Cleared Nov 16, 1993
STATAK & MINI-STATAK SOFT TISSUE ATTACHMENT DEVICE
K926384 · JDR
Zimmer, Inc.
Orthopedic · 329d
Cleared Nov 16, 1993
MG II POROUS KNEE SYSTEM FEMORAL COMPONENTS
K930831 · JWH
Zimmer, Inc.
Orthopedic · 272d
Cleared Nov 09, 1993
OSTEOMED GREAT TOE SYSTEM
K922211 · LZJ
Osteomed Corp.
Orthopedic · 546d
Cleared Nov 08, 1993
HA ANATOMIC HIP PROSTH W/TI-NIDIUM SURF HARD PROCE
K925607 · MEH
Zimmer, Inc.
Orthopedic · 368d
Cleared Nov 05, 1993
SYNTHES(U.S.A.) ANTERIOR SPINAL PLATE
K925351 · KWQ
Synthes (Usa)
Orthopedic · 379d
Cleared Oct 27, 1993
EXATECH MCS POROUS COATED TOTAL HIP FEMORAL STEM
K921113 · LPH
Exactech, Inc.
Orthopedic · 597d
Cleared Oct 27, 1993
EXACTECH MCS POROUS COATED TOTAL HIP ACETABULAR
K921114 · LPH
Exactech, Inc.
Orthopedic · 597d
Cleared Oct 27, 1993
BONE SCREWS
K923841 · HWC
Instrument Makar, Inc.
Orthopedic · 453d
Cleared Oct 27, 1993
AXIOM TOTAL KNEE SYSTEM, MODULAR TIBIAL TRAY
K924698 · JWH
Orthomet, Inc.
Orthopedic · 405d
Cleared Oct 27, 1993
ANSPACH BONE RIVET, ANSPACH SUTURE ANCHOR
K925328 · HWC
Anspach Mfg., Inc.
Orthopedic · 371d
Cleared Oct 27, 1993
THE DE SOUTTER M193 REAMER
K930784 · HSZ
De Soutter Medical, Ltd.
Orthopedic · 253d
Cleared Oct 27, 1993
THE DE SOUTTER M182 DRILL
K930785 · HSZ
De Soutter Medical, Ltd.
Orthopedic · 253d