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
13993–14016 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Oct 03, 1997
MAGELLAN MAGNETIC DISTAL TARGETING SYSTEM(PROPOSED NAME), PRODUCT LINE EXTENSION
K971056 · HSB
Wrightmedicaltechnologyinc
Orthopedic · 193d
Cleared Oct 01, 1997
LEIBINGER SELF-DRILLING SCREW
K970912 · HWC
Howmedica Leibinger, Inc.
Orthopedic · 203d
Cleared Oct 01, 1997
DISTALLY FIXED HIP STEM
K971523 · MEH
Sulzer Orthopedics, Inc.
Orthopedic · 156d
Cleared Oct 01, 1997
DEPUY DUPONT ABSORBABLE SET SCREW
K972494 · HWC
Depuy, Inc.
Orthopedic · 90d
Cleared Oct 01, 1997
APOLLO REVISION/CONSTRAINED KNEE SYSTEM
K972501 · JWH
Sulzer Orthopedics, Inc.
Orthopedic · 90d
Cleared Oct 01, 1997
PRECEDENT REVISION HIP SYSTEM
K972637 · LZO
Sulzer Orthopedics, Inc.
Orthopedic · 78d
Cleared Oct 01, 1997
M-2 ANTERIOR PLATE SYSTEM
K972718 · KWQ
Acromed Corp.
Orthopedic · 72d
Cleared Sep 29, 1997
ADVANCE KNEE SYSTEM
K972626 · JWH
Wrightmedicaltechnologyinc
Orthopedic · 77d
Cleared Sep 26, 1997
INNOVASIVE 2.3MM ROC XS SUTURE BONE FASTENER
K972438 · MBI
Innovasive Devices, Inc.
Orthopedic · 88d
Cleared Sep 25, 1997
OSTEONICS OMNIFIT-C CEMENTED HIP STEM (LINE EXTENSION)
K972460 · JDI
Osteonics Corp.
Orthopedic · 86d
Cleared Sep 25, 1997
BLACKSTONE MEDICAL, INC. LAPAROSCOPIC DISC REMOVAL SYSTEM
K972768 · HRX
Blackstone Medical, Inc.
Orthopedic · 63d
Cleared Sep 25, 1997
OSTEO BOS SYSTEM IN STAINLESS STEEL
K973204 · HRS
Osteonics Corp.
Orthopedic · 30d
Cleared Sep 23, 1997
V40 ZIRCONIA FEMORAL HEADS
K972361 · LZO
Howmedica, Inc.
Orthopedic · 90d
Cleared Sep 19, 1997
INTER-OP HA POROUS ACETABULAR SYSTEM (HA/CSTI)
K972393 · LPH
Sulzer Orthopedics, Inc.
Orthopedic · 85d
Cleared Sep 19, 1997
DEPUY MOTECH MOSS-MIAMI SPINAL SYSTEM
K972568 · MNH
Depuy, Inc.
Orthopedic · 71d
Cleared Sep 19, 1997
ACUFEX SCREW CANNULA
K972599 · HWC
Smith & Nephew Endoscopy, Inc.
Orthopedic · 67d
Cleared Sep 19, 1997
MARCHETTI-VICENZI INTRAMEDULLARY NAIL, HUMERAL
K972692 · HSB
Zimmer, Inc.
Orthopedic · 64d
Cleared Sep 12, 1997
DEPUY DUPONT ORTHOPAEDICS FINGER JOINT PROSTHESIS
K970544 · KYJ
Depuy, Inc.
Orthopedic · 212d
Cleared Sep 11, 1997
ULTIMA AND ULTIMA LX CEMENTED FEMORAL STEM
K972435 · JDI
Johnson & Johnson Professionals, Inc.
Orthopedic · 73d
Cleared Sep 11, 1997
ALTA PLATING SYSTEM
K972479 · HRS
Howmedica Corp.
Orthopedic · 72d
Cleared Sep 10, 1997
BONE PLATE WITH CABLES
K972223 · HRS
Pioneer Surgical Technology
Orthopedic · 89d
Cleared Sep 10, 1997
OSTEO BOS SYSTEM
K972323 · HRS
Osteonics Corp.
Orthopedic · 82d
Cleared Sep 04, 1997
STRYKER SYSTEM 4000 HEAVY DUTY BATTERY POWERED EQUIPMENT
K972367 · KIJ
Stryker Instruments
Orthopedic · 71d
Cleared Sep 04, 1997
SYNTHES (USA) FLEXIBLE HUMERAL NAIL(FLEX NAIL) SYSTEM
K972516 · JDS
Synthes (Usa)
Orthopedic · 59d