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510(k) K973031

STABILIZER SOFT TISSUE ANCHOR 5MM MODEL TA1005, ANCHOR INSERTER/SUTURE ORGANIZER 5MM AI1005, STABILIZER DRILL 5MM NONSTE by R. Thomas Grotz, M.D., Inc. — Product Code MRI

K973031 is an FDA 510(k) premarket notification submitted by R. Thomas Grotz, M.D., Inc. for the device "STABILIZER SOFT TISSUE ANCHOR 5MM MODEL TA1005, ANCHOR INSERTER/SUTURE ORGANIZER 5MM AI1005, STABILIZER DRILL 5MM NONSTE". The FDA issued a decision of Substantially Equivalent on November 3, 1997. The device falls under product code MRI (Orthosis, Truncal/Orthosis, Limb), a Class I device regulated under 21 CFR 890.3490. R. Thomas Grotz, M.D., Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 3, 1997
Date Received
August 14, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Orthosis, Truncal/Orthosis, Limb
Device Class
Class I
Regulation Number
890.3490
Review Panel
PM
Submission Type

Other clearances by R. Thomas Grotz, M.D., Inc.

  • K984200 — STABILIZER SOFT TISSUE ANCHOR, 5 AND 8MM; ANCHOR INSERTER, 5 AND 8MM; STABILIZER (January 21, 1999)
  • K965111 — STABILIZER SOFT TISSUE ANCHOR MODEL NUMBER TA1005, TA1008, ANCHOR INSERTER/SUTUR (February 18, 1997)
  • K964927 — STABILIZER SOFT TISSUE ANCHOR, 8MM MODEL TA1008, ANCHOR INSERTER/SUTURE ORGANIZE (February 7, 1997)

Other clearances for product code MRI

  • K923880 — ORLAU SWIVEL WALKER (September 30, 1996)

FDA data resources