Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
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- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart B—Neurological Diagnostic DevicesCFR Sub-Part
- Subpart B—Physical Medicine Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart D—Physical Medicine Prosthetic DevicesCFR Sub-Part
- Subpart E—Neurological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- QQOCranial Measurement Software1Product Code
- HSTApparatus, Traction, Non-Powered1Product Code
- K162702Teeter Manual Inversion Table; Teeter Gravity Boots; Teeter Forward Rotation Decompression Device; Teeter Portable Decompression Device; Teeter Horizontal Decompression Table1Cleared 510(K)
- K110858LO-BAK TRAX1Cleared 510(K)
- K984190BACK-ON-TRAC, MODEL 101BOT1Cleared 510(K)
- K872121K AND D HOME TRACT1Cleared 510(K)
- K870212ARTHROSCOPIC SHOULDER HOLDER1Cleared 510(K)
- K870125EXTREMITY ELEVATOR1Cleared 510(K)
- K870102TUPPER TROLLEY1Cleared 510(K)
- K864765MODEL 668, TRACTION SPLINT, ADULT1Cleared 510(K)
- K862874THE TOWERED 90/90 UNIT1Cleared 510(K)
- K860037SUSPENDER ORTHOPEDIC SUSPENSION DEVICE1Cleared 510(K)
- K855179TRANSFER-TRAX (TM) SPLINT TRACTION1Cleared 510(K)
- K844239NEC-KRADLE BY VENCOR1Cleared 510(K)
- K841388ACUFEX SHOULDER HOLDER1Cleared 510(K)
- K841368HYPERBARIC OXYGEN GURNEY-1Cleared 510(K)
- K831888COMPUTERIZED TOMOGRAPHY-HYPERBARIC OXYG1Cleared 510(K)
- K830244TRACTION ACCESSORIES1Cleared 510(K)
- K823813TRACTION ACCESSORIES1Cleared 510(K)
- K823395TRACTION-STEEL FRAMING SYSTEM1Cleared 510(K)
- K823372OCTAGONAL ALUMINUM FRAMING SYSTEM1Cleared 510(K)
- K823392FOREARM REDUCTION UNIT1Cleared 510(K)
- K822993SENATEK1Cleared 510(K)
- K821522CERVITRAC TRACTION FRAME & CORD1Cleared 510(K)
- K820612TENSOPLAST SKIN TRACTION KIT1Cleared 510(K)
- K813017NECKTRAC1Cleared 510(K)
- K813016ZEE TRACTION SPLINT1Cleared 510(K)
- K812779EXTENSIONS-LUSATZTISCH1Cleared 510(K)
- K803021UPPER EXTREMITY TRACTION DEVICE1Cleared 510(K)
- K802555COTTRELL 90/90 BACKTRAC1Cleared 510(K)
- K802072PROT-A-TRAC1Cleared 510(K)
- K792248TAYLOR TRACTION CORD1Cleared 510(K)
- K791919BAC JAC1Cleared 510(K)
- K791396MEDI-TRAK PORTABLE TRACTION DEVICE1Cleared 510(K)
- K790729OCTAGONAL ALUMINUM FRAMING SYSTEM1Cleared 510(K)
- K771988VERTETRAC1Cleared 510(K)
- K781647BACK TRAC1Cleared 510(K)
- K780228TRACTION UNITS1Cleared 510(K)
- K780233TRACTION WEIGHT BAGS1Cleared 510(K)
- K770080BAKER MOBILE TRACTION1Cleared 510(K)
- ONONeurosurgical Laser With Mr Thermography2Product Code
- Subpart F—Cardiovascular Therapeutic DevicesCFR Sub-Part
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
ACUFEX SHOULDER HOLDER
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K841388
- 510(k) Type
- Traditional
- Applicant
- ACUFEX MICROSURGICAL, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 5/16/1984
- Days to Decision
- 43 days