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
16465–16488 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Sep 12, 1989
KRONNER SACRAL PIN GUIDE
K895172 · LXH
Kronner Medical
Orthopedic · 33d
Cleared Sep 12, 1989
SKELETAL FIXATION PIN
K895173 · JDW
Kronner Medical
Orthopedic · 33d
Cleared Sep 12, 1989
CORTICAL SCREW
K895217 · HWC
Orthopedic Systems, Inc.
Orthopedic · 25d
Cleared Sep 12, 1989
CANCELLOUS SCREW SHORT THREAD DIAMETER 6.5MM
K895218 · HWC
Orthopedic Systems, Inc.
Orthopedic · 25d
Cleared Sep 12, 1989
CANCELLOUS SCREW LONG THREAD DIAMETER 6.5MM
K895219 · HWC
Orthopedic Systems, Inc.
Orthopedic · 25d
Cleared Sep 11, 1989
P.F.C. HIP SYSTEM POROUS COATED FEMORAL COMPONENT
K893872 · KWY
Johnson & Johnson Professionals, Inc.
Orthopedic · 108d
Cleared Sep 11, 1989
OMNIFIT SELF TAPPING CANCELLOUS BONE SCREWS
K894124 · HWC
Osteonics Corp.
Orthopedic · 91d
Cleared Sep 11, 1989
ACE ORTHOPAEDIC WASHERS
K895107 · HTN
Buckman Co., Inc.
Orthopedic · 27d
Cleared Sep 11, 1989
INTERMEDICS POWER BROACH IMPACTOR
K895121 · HSZ
Intermedics Orthopedics
Orthopedic · 27d
Cleared Sep 05, 1989
MOD. FEMORAL COMP. NON-BEADED & BASIC ACE. SHELL
K894148 · JDI
Howmedica Corp.
Orthopedic · 83d
Cleared Sep 01, 1989
ZIRCONIA CERAMIC HEAD (YITRIA STABILIZED)
K885069 · LZO
Richards Medical Co., Inc.
Orthopedic · 267d
Cleared Sep 01, 1989
ATH CERAMIC UHMWPE TOTAL HIP SYSTEM
K890472 · LZO
Kinamed, Inc.
Orthopedic · 214d
Cleared Aug 30, 1989
CYPRESS CANNULATED BONE SCREW
K894830 · HWC
Cypress Medical Mfg., Inc.
Orthopedic · 30d
Cleared Aug 30, 1989
STAPLE FIXATION SYSTEM
K894929 · JDR
Concept, Inc.
Orthopedic · 28d
Cleared Aug 28, 1989
DANEK WRIST FIXATOR
K891066 · KTT
Danek Medical, Inc.
Orthopedic · 180d
Cleared Aug 28, 1989
PREMIER-TOTAL HIP
K894051 · LWJ
Intermedics Orthopedics
Orthopedic · 82d
Cleared Aug 21, 1989
DEPUY CANNULATED BONE SCREW
K893512 · HWC
Depuy, Inc.
Orthopedic · 108d
Cleared Aug 18, 1989
DYONICS DISPOSABLE ARTHROSCOPIC SURGICAL KNIFE
K894728 · HRX
Dyonics, Inc.
Orthopedic · 23d
Cleared Aug 11, 1989
TRACER DYNAMIC AXIAL FIXATION
K892638 · JEC
Tracer Medical
Orthopedic · 121d
Cleared Aug 09, 1989
INTERMEDICS APR(TM) II FEMORAL COMPONENT
K890450 · JDJ
Intermedics Orthopedics
Orthopedic · 191d
Cleared Aug 09, 1989
ARC-2F ACETABULAR CUP
K893785 · LWJ
Protek, Inc.
Orthopedic · 79d
Cleared Aug 07, 1989
VECSEI EXPANDING SCREW
K892925 · HWC
Howmedica Corp.
Orthopedic · 108d
Cleared Aug 07, 1989
MINI LIGHTSCOPE SET, LIGHTSCOPE JR. SET
K894558 · HRX
Optik
Orthopedic · 18d
Cleared Aug 03, 1989
MG II POROUS TOTAL KNEE SYSTEM
K892800 · JWH
Zimmer, Inc.
Orthopedic · 108d