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
15265–15288 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jul 06, 1994
STABILITY HIP STEM WITH POROCOAT
K934457 · LZO
Depuy, Inc.
Orthopedic · 296d
Cleared Jun 30, 1994
ORTHOLOC ADVANTIM L.S. TIBIAL COMPONENT
K932911 · JWH
Dow Corning Wright
Orthopedic · 379d
Cleared Jun 30, 1994
OSTEO INTERLOCKING-COMPRESSION NAIL
K933340 · HSB
Osteo AG
Orthopedic · 357d
Cleared Jun 29, 1994
ALPHA SPINAL SYSTEM
K930515 · KWP
Alphatec Mfg., Inc.
Orthopedic · 513d
Cleared Jun 29, 1994
D-C-S SYSTEM
K930657 · KWP
Pina-Vertriebs
Orthopedic · 505d
Cleared Jun 29, 1994
SMITH AND NEPHEW SPINE DEFLECTING FORCEPS
K940222 · HRX
Smith & Nephew, Inc.
Orthopedic · 162d
Cleared Jun 29, 1994
TNCO, INC. ARTHROSCOPIC SURGICAL INSTRUMENTS
K940554 · HRX
Tnco, Inc.
Orthopedic · 142d
Cleared Jun 28, 1994
ACUFEX SMOOTH AND THREADED PINS
K931836 · HTY
Acufex Microsurgical, Inc.
Orthopedic · 441d
Cleared Jun 28, 1994
BIO-PREP CEMENT RESTRICTOR
K931847 · LZN
Biomedical Devices, Inc.
Orthopedic · 441d
Cleared Jun 28, 1994
ACUFEX DISPOSABLE MENISCAL CANNULA
K932090 · HRX
Acufex Microsurgical, Inc.
Orthopedic · 424d
Cleared Jun 28, 1994
ACUMED FLEXIBLE CANNULA
K932099 · HRX
Acu Med, Inc.
Orthopedic · 421d
Cleared Jun 21, 1994
GDLH VARIABLE ANGLE CONNECTOR
K934582 · KWP
Danek Group, Inc.
Orthopedic · 271d
Cleared Jun 16, 1994
QUICKANCHOR II
K931253 · JDR
Mitek Surgical Products, Inc.
Orthopedic · 461d
Cleared Jun 16, 1994
ACUFEX SURETAC
K931519 · JDR
Acufex Microsurgical, Inc.
Orthopedic · 447d
Cleared Jun 16, 1994
ACE PELVIC STABILIZER
K933968 · JEC
Ace Medical Co.
Orthopedic · 304d
Cleared Jun 16, 1994
MORPHOMETRIC TOTAL HIP PROSTHESIS
K935185 · LZO
Landos, Inc.
Orthopedic · 233d
Cleared Jun 15, 1994
VARIABLE ANGULAR HOLD BONE PLATE SYSTEM
K930480 · HRS
Smith & Nephew Richards, Inc.
Orthopedic · 502d
Cleared Jun 15, 1994
TITAN DYSPLASIC TOTAL HIP PROSTHESIS
K932935 · LZO
Landos, Inc.
Orthopedic · 364d
Cleared Jun 15, 1994
CS-PLUS STEM
K936214 · JDI
Encore Orthopedics, Inc.
Orthopedic · 169d
Cleared Jun 14, 1994
EXACTECH ZIRAMIC FEMORAL HEAD COMPONENT
K931617 · LZO
Exactech, Inc.
Orthopedic · 438d
Cleared Jun 14, 1994
EXETER ALL PLASTIC ACETABULAR COMPONENT
K936132 · JDI
Howmedica, Inc.
Orthopedic · 173d
Cleared Jun 09, 1994
P.F.C. BIPOLAR HIP SYSTEM
K931655 · KWY
Johnson & Johnson Orthopaedics, Inc.
Orthopedic · 430d
Cleared Jun 08, 1994
SL-PLUS AND SLR-PLUS
K932481 · JDI
Encore Orthopedics, Inc.
Orthopedic · 380d
Cleared Jun 07, 1994
SPOON PLATE
K931690 · HRS
Onyx Medical Corp.
Orthopedic · 428d