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
17281–17304 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Aug 27, 1984
DRILL BIT
K841629 · HTW
Plastafil, Inc.
Orthopedic · 130d
Cleared Aug 24, 1984
BIAS TOTAL HIP
K842906 · JDI
Zimmer, Inc.
Orthopedic · 31d
Cleared Aug 21, 1984
ALL-HANDS MEDICAL SUPPLY SUTURE REMOVAL
K842953 · HRR
All-Hands Medical Supply, Inc.
Orthopedic · 25d
Cleared Aug 18, 1984
AMERICAN EDWARDS LABS FLEXISCOPE
K841607 · HRX
American Edwards Laboratories
Orthopedic · 121d
Cleared Aug 17, 1984
AMER. EDWARDS LAB FLEXISCOPE OBTURATOR
K842323 · HRX
American Edwards Laboratories
Orthopedic · 65d
Cleared Aug 17, 1984
HOWMEDICA KINEMATIC II TIBIAL WEDGE
K842367 · HRY
Howmedica Corp.
Orthopedic · 63d
Cleared Aug 14, 1984
ARTHROSCOPY KNIVES
K842820 · HTS
Medtech Industries, Inc.
Orthopedic · 26d
Cleared Aug 02, 1984
PARTIALLY THREADED BONE FIX. PIN
K842293 · JDW
Warsaw Orthopedic, Inc.
Orthopedic · 50d
Cleared Jul 23, 1984
WIRE
K841628 · HXN
Plastafil, Inc.
Orthopedic · 95d
Cleared Jul 20, 1984
NEW JERSEY ACETABULAR COMPONENT &
K842202 · JDI
Endomedics, Inc.
Orthopedic · 46d
Cleared Jul 20, 1984
NEW JERSEY FEMORAL RESURFACING COMPONENT
K842233 · KXA
Endomedics, Inc.
Orthopedic · 45d
Cleared Jul 20, 1984
NEW JERSEY FEMORAL STEM
K842234 · KWL
Endomedics, Inc.
Orthopedic · 45d
Cleared Jul 11, 1984
SOFT-TISSUE INSTRUMENT
K841622 · HWQ
Plastafil, Inc.
Orthopedic · 83d
Cleared Jul 11, 1984
SLOTTED SOFT-TISSUE INSTRUMENT
K841623 · HWQ
Plastafil, Inc.
Orthopedic · 83d
Cleared Jul 03, 1984
CEMENTLESS HIP PROSTHESIS
K840271
Mecron Medical Products, Inc.
Orthopedic · 162d
Cleared Jun 25, 1984
SRC TOTAL KNEE
K841022
Joint Medical Products Corp.
Orthopedic · 105d
Cleared Jun 25, 1984
PENNSYLVANIA HOSPITAL HIP SYS
K841437 · KWL
Biomet, Inc.
Orthopedic · 80d
Cleared Jun 19, 1984
UNIVERSAL SELF-ALIGNING ACETABULAR COM
K834035 · JDI
Orthopedic Equipment Co., Inc.
Orthopedic · 209d
Cleared Jun 19, 1984
6.5MM HEX HANDLE
K841969 · LXH
Stainless Mfg., Inc.
Orthopedic · 36d
Cleared Jun 19, 1984
CAMELBACK HANDLE-K841969-LABELING
K841970 · LXH
Stainless Mfg., Inc.
Orthopedic · 36d
Cleared Jun 19, 1984
2.5MM & 4MM PROBE K841969-LABELING
K841971 · HXB
Stainless Mfg., Inc.
Orthopedic · 36d
Cleared Jun 19, 1984
4MM & 5MM FILE
K841981 · HTP
Stainless Mfg., Inc.
Orthopedic · 36d
Cleared Jun 05, 1984
ANTRUM NEEDLE-WOLF TYPE
K841300
Popper & Sons, Inc.
Orthopedic · 67d
Cleared May 30, 1984
POLY PLUG CEMENT RESTRICTOR
K840242 · JDS
Latham Manufacturer
Orthopedic · 131d