FDA.reportPublic FDA data

Orthopaedic bone pin, non-bioabsorbable

Definition
A thin, implantable rod intended to be used for the stabilization of a bone fracture or bone grafts, or for an osteotomy or arthrodesis. It is typically drilled into bone and may be smooth or threaded, solid or cannulated, and/or semi-flexible. Also known as a K-Wire, it may in addition be intended to assist with the introduction of a surgical instrument and/or implant; it is not intended for implantation into the intramedullary canal (i.e., not a nail). It is made of a material that is not chemically degraded or absorbed by natural body processes (e.g., stainless steel). Some designs may have a break-off shank and/or be coated to improve long-term fixation. This is a single-use device.
GUDID devices
685
Last updated
2025-07-08 17:11:00

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00763000885045n/aMEDTRONIC SOFAMOR DANEK, INC.70809012025-06-30
B8037104623ORTHOMEDORTHO-MED, INC.OM 71-0462R2020-05-21
B8037104653ORTHOMEDORTHO-MED, INC.OM 71-0465R2020-05-28
B8037104683ORTHOMEDORTHO-MED, INC.OM 71-0468R2020-05-28
B8037104693ORTHOMEDORTHO-MED, INC.OM 71-0469R2020-05-28
B8037105283ORTHOMEDORTHO-MED, INC.OM 71-0528R2020-06-01
B8037105293ORTHOMEDORTHO-MED, INC.OM 71-0529R2020-06-01
B8037106003ORTHOMEDORTHO-MED, INC.OM 71-0600R2020-06-01
B8037106033ORTHOMEDORTHO-MED, INC.OM 71-0603R2020-06-01
B8037106063ORTHOMEDORTHO-MED, INC.OM 71-0606R2020-06-01
B8037106093ORTHOMEDORTHO-MED, INC.OM 71-0609R2020-06-01
B8037106123ORTHOMEDORTHO-MED, INC.OM 71-0612R2020-06-01
B8037106153ORTHOMEDORTHO-MED, INC.OM 71-0615R2020-06-01
B8037106183ORTHOMEDORTHO-MED, INC.OM 71-0618R2020-06-01
B8037107003ORTHOMEDORTHO-MED, INC.OM 71-0700R2020-06-10
B8037107033ORTHOMEDORTHO-MED, INC.OM 71-0703R2020-06-10
B8037107063ORTHOMEDORTHO-MED, INC.OM 71-0706R2020-06-10
B8037107093ORTHOMEDORTHO-MED, INC.OM 71-0709R2020-06-10
B8037107123ORTHOMEDORTHO-MED, INC.OM 71-0712R2020-06-10
B8037107153ORTHOMEDORTHO-MED, INC.OM 71-0715R2020-06-10
B8037107183ORTHOMEDORTHO-MED, INC.OM 71-0718R2020-06-10
B8037107193ORTHOMEDORTHO-MED, INC.OM 71-0719R2020-06-12
B8037107483ORTHOMEDORTHO-MED, INC.OM 71-0748R2020-06-10
B8037107503ORTHOMEDORTHO-MED, INC.OM 71-0750R2020-06-05
B8037107533ORTHOMEDORTHO-MED, INC.OM 71-0753R2020-06-05
B8037107563ORTHOMEDORTHO-MED, INC.OM 71-0756R2020-06-05
B8037107593ORTHOMEDORTHO-MED, INC.OM 71-0759R2020-06-05
B8037107623ORTHOMEDORTHO-MED, INC.OM 71-0762R2020-06-05
B8037107653ORTHOMEDORTHO-MED, INC.OM 71-0765R2020-06-05
B8037107683ORTHOMEDORTHO-MED, INC.OM 71-0768R2020-06-08
B8037107693ORTHOMEDORTHO-MED, INC.OM 71-0769R2020-06-08
B8037107703ORTHOMEDORTHO-MED, INC.OM 71-0770R2020-06-08
00857676008805K-Wire Accessory PackEca Medical Instruments10112025-06-17
00197157015046ZAVATION GUIDE WIREZavation LLC989-1008-32025-06-04
00197157015053ZAVATION RODZavation LLC14G006742025-06-04
00197157014971ZAVATION GUIDE WIREZavation LLC989-1009-22025-06-03
00197157014988ZAVATION GUIDE WIREZavation LLC989-1009-12025-06-03
00197157014995ZAVATION GUIDE WIREZavation LLC989-1008-22025-06-03
00197157015008ZAVATION GUIDE WIREZavation LLC989-1008-12025-06-03
00197157015015ZAVATION GUIDE WIREZavation LLC989-1009-42025-06-03
00197157015022ZAVATION GUIDE WIREZavation LLC989-1009-32025-06-03
00197157015039ZAVATION GUIDE WIREZavation LLC989-1008-42025-06-03
00763000884536n/aMEDTRONIC SOFAMOR DANEK, INC.70809022025-05-18
00840180540299General InstrumentsALPHATEC SPINE, INC.CI-118602025-05-13
00849771049012NAKEY SURGICAL, INC.K-Wires and Steinmann Pins2025-04-30
00849771049128NAKEY SURGICAL, INC.K-Wires and Steinmann Pins2025-04-30
00840124518520FuzeFix LargeFUSION ORTHOPEDICS, LLCCD-FX-00242025-04-08
00840124518537FuzeFix LargeFUSION ORTHOPEDICS, LLCCD-FX-05242025-04-08
00840124518544FuzeFix LargeFUSION ORTHOPEDICS, LLCCD-FX-02142025-04-08
07630894821080APTUSMedartis AGA-5042.51/4S2024-03-22
07630894821097APTUSMedartis AGA-5040.512023-02-24
07630894821103APTUSMedartis AGA-5040.612023-02-24
07630894821110APTUSMedartis AGA-5042.612023-02-24
24053613292591Steinmann Pin plain Ø 1.60mm Diamond - Round shankGebr. Brasseler GmbH & Co. KGSP003.177.0162025-03-25
00194613037376MSI Precision Specialty InstrumentsMed Saver, Inc.G17502025-03-21
00194613037406MSI Precision Specialty InstrumentsMed Saver, Inc.G17592025-03-21
00194613038793MSI Precision Specialty InstrumentsMed Saver, Inc.S19242025-03-21
00194613038823MSI Precision Specialty InstrumentsMed Saver, Inc.S19352025-03-21
00194613038847MSI Precision Specialty InstrumentsMed Saver, Inc.S19452025-03-21
00194613038878MSI Precision Specialty InstrumentsMed Saver, Inc.S29282025-03-21
24053613292683Steinmann Pin plain Ø 1.60mm Trocar - Round shankGebr. Brasseler GmbH & Co. KGSAK1-00052025-03-17
24053613292911Steinmann Pin plain Ø 1.60mm Trocar - Round shankGebr. Brasseler GmbH & Co. KGP82-912-16002025-03-17
04042409451348NAaap Implantate AGNK 1024-252025-02-26
00840124518261FuzeFix LargeFUSION ORTHOPEDICS, LLCCD-FX-00262025-02-20
00840124518278FuzeFix LargeFUSION ORTHOPEDICS, LLCCD-FX-05262025-02-20
00842188128233WireformsTrimed, INC.VBP32-12025-02-12
00842188128240WireformsTrimed, INC.VBP42-12025-02-12
00842188128257WireformsTrimed, INC.DBP27-12025-02-12
00842188128264WireformsTrimed, INC.VBP32-22025-02-12
00842188128271WireformsTrimed, INC.DBP32-22025-02-12
00842188128288WireformsTrimed, INC.DBP27-22025-02-12
00842188128295WireformsTrimed, INC.VBP42-22025-02-12
00842188129735WireformsTrimed, INC.DBP32-12025-02-12
M986AC091000Photodynamic Bone Stabilization SystemILLUMINOSS MEDICAL, INC.AC091002025-01-21
M986AC091200Photodynamic Bone Stabilization SystemILLUMINOSS MEDICAL, INC.AC091202025-01-21
M986AC13100700Photodynamic Bone Stabilization SystemILLUMINOSS MEDICAL, INC.AC13100702025-01-21
M986AC13100900Photodynamic Bone Stabilization SystemILLUMINOSS MEDICAL, INC.AC13100902025-01-21
M986AC13101200Photodynamic Bone Stabilization SystemILLUMINOSS MEDICAL, INC.AC13101202025-01-21
M986UM040400Photodynamic Bone Stabilization SystemILLUMINOSS MEDICAL, INC.UM040402025-01-21
M986UM050400Photodynamic Bone Stabilization LED Light SystemILLUMINOSS MEDICAL, INC.UM050402025-01-21