Prosthesis, Tendon, Passive
Orthopedic · 21 CFR 888.3025
Recent MDR events
15 adverse event reports on file
- TENDON SPACER SWANSON/HUNTER 24CM X 3MM FLEXSPANMay 14, 2025MalfunctionWright Medical Technology Inc3010667733-2025-00561
- HUNTER TENDONMar 19, 2021InjuryWright Medical Technology, Inc.1043534-2021-00044
- UNKNOWN SHOULDER HUMERAL STEMSNov 8, 2019InjuryDepuy Orthopaedics Inc Us1818910-2019-115432
- HUNTER TENDONMay 6, 2019InjuryWright Medical Technology, Inc.1043534-2019-00057
- HUNTER TENDONMay 6, 2019InjuryWright Medical Technology, Inc.1043534-2019-00058
- SWANSON HUNTER ROD SIZER SETApr 24, 2018InjuryWright Medical Technology, Inc.1043534-2018-00030
- SWANSON HUNTER ROD SIZER SETJul 5, 2016MalfunctionWright Medical Technology, Inc.1043534-2016-00064
- HUNTER TENDON RODSep 23, 2014InjuryWright Medical Technology, Inc.1043534-2014-00153
- ALLSET GOLD SSP HLA-ABDRDQ LOW RES KIT - 10Oct 2, 2013MalfunctionLife Technologies Corporation2244574-2013-00025
- HUNTER TENDON RODJun 14, 2013InjuryWright Medical Technology, Inc.1043534-2013-01044
Event type breakdown
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
14 firms currently registered for this product code
Straits Orthopaedics (mfg) Sdn Bhd
Perai Pulau Pinang, MY
Stryker Sustainability Solutions Phoenix
Phoenix, AZ, US
Wright Medical Technology, Inc.
Arlington, TN, US
Technical Products, Inc.
Buford, GA, US
Straits Orthopaedics (mfg) Sdn Bhd
Bandar Cassia Pulau Pinang, MY
Wright Medical Technology, Inc.
Arlington, TN, US
Straits Orthopaedics (mfg) Sdn Bhd
Simpang Ampat Pulau Pinang, MY
Simagec
ROUSSET CEDEX Bouches-du-Rhone, FR
Bbf Sterilisationsservice Gmbh
Kernen Baden-Wurttemberg, DE
Askorn Medical
Cesson Sevigne Bretagne, FR
510(k) clearances
11 clearances for this product code
- Askorn MedicalJan 10, 2025
K243477 · Universal Tendon Spacer
- Medist InternationalMar 29, 2000
K000019 · SINGLE SIZE TENDON SPACER
- Technical Products, Inc.Dec 5, 1997
K973385 · OVAL SHAPES
- Avanta Orthopaedics, Inc.Mar 25, 1997
K964359 · AVANTA ORTHOPAEDICS TENDON SPACER
- Phoenix Bioengineering, Inc.Dec 30, 1993
K930125 · PHOENIX BONE SCREWS PBS-TYPE SERIES
- Holter-Hausner Intl.Sep 28, 1987
K872285 · H-H HUNTER ACTIVE TENDON IMPLANT DC
- Holter-Hausner Intl.Sep 28, 1987
K872293 · H-H HUNTER ACTIVE TENDON IMPLANT BC
- Holter-Hausner Intl.Sep 28, 1987
K872284 · H-H HUNTER ACTIVE TENDON IMPLANT PC