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
15313–15336 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared May 12, 1994
IMPLEX A-230 POROUS ACETABULAR CUP SYST. CEMENTED
K932924 · LPH
Implex Corp.
Orthopedic · 331d
Cleared May 09, 1994
SELECT(R) SHOULDER ALL-POLY GLENOID
K931114 · KWT
Intermedics Orthopedics
Orthopedic · 431d
Cleared May 06, 1994
REFLECTION ACETABULAR COMPONENT
K932755 · LPH
Smith & Nephew Richards, Inc.
Orthopedic · 350d
Cleared May 06, 1994
ACUFEX ARTHROSCOPIC SHOULDER GUIDE SYSTEM
K940481 · HRX
Acufex Microsurgical, Inc.
Orthopedic · 93d
Cleared May 05, 1994
CO-CR ANSWER FEMORAL COMPONENT
K931194 · JDG
Biomet, Inc.
Orthopedic · 422d
Cleared May 04, 1994
AMSET(TM) CANNULATED BONE SCREW
K931538 · HWC
Advanced Med/Surg, Inc.
Orthopedic · 401d
Cleared May 04, 1994
CANNULATED CANCELLOUS SCREW
K931680 · HWC
Onyx Medical Corp.
Orthopedic · 394d
Cleared May 04, 1994
EPIPHYSIS PLATE
K931684 · HRS
Onyx Medical Corp.
Orthopedic · 394d
Cleared May 04, 1994
T-PLATE
K931692 · HRS
Onyx Medical Corp.
Orthopedic · 394d
Cleared May 04, 1994
TSRH(R) TOP TIGHT T-BOLT-VARI ANGLE/SCREW/PARAGON
K933205 · KWP
Danek Medical, Inc.
Orthopedic · 307d
Cleared May 04, 1994
MINI FRAGMENT PLATE
K934614 · HRS
Onyx Medical Corp.
Orthopedic · 219d
Cleared May 03, 1994
AME(R) UNIVERSIAL CABLE SYSTEM
K932687 · JDQ
American Medical Electronics, Inc.
Orthopedic · 334d
Cleared May 03, 1994
IMPLEX A-230 POROUS ACETABULAR CUP SYST.CEMENTLESS
K932923 · LPH
Implex Corp.
Orthopedic · 322d
Cleared May 03, 1994
FOUNDATION ALL POLY CUP
K934169 · JDI
Encore Orthopedics, Inc.
Orthopedic · 249d
Cleared May 02, 1994
LOW PROFILE MID CROSS BRACING
K931225 · KWP
Advanced Spine Fixation Systems, Inc.
Orthopedic · 418d
Cleared Apr 29, 1994
SYNTHES (USA) UNIV SPINE ROD/SACRAL SCREW FIX SYST
K930891 · KWP
Synthes (Usa)
Orthopedic · 431d
Cleared Apr 29, 1994
COOL CUT
K931429 · HWE
Mitab
Orthopedic · 403d
Cleared Apr 29, 1994
RMHS MONOLITHIC FEMORAL COMPONENT
K931642 · LPH
Smith & Nephew Richards, Inc.
Orthopedic · 392d
Cleared Apr 29, 1994
EXACTECH ALL POLY ACETABULAR CUP
K934253 · JDZ
Exactech, Inc.
Orthopedic · 241d
Cleared Apr 29, 1994
TRILOGY ACETABULAR SYSTEM
K934765 · LPH
Zimmer, Inc.
Orthopedic · 206d
Cleared Apr 28, 1994
MOUNTABLE KNIFE
K931323 · HRX
Esco Medical
Orthopedic · 408d
Cleared Apr 28, 1994
ACE 6.5 MM BONE SCREW
K931652 · HWC
Ace Medical Co.
Orthopedic · 388d
Cleared Apr 28, 1994
COBALT CHROME GEMINI
K934909 · LWJ
Depuy, Inc.
Orthopedic · 196d
Cleared Apr 28, 1994
STRYKER ARTHROSCOPIC MANUAL SURGICAL INSTRUMENTS
K935221 · HRX
Stryker Endoscopy
Orthopedic · 178d