STABILIZER SOFT TISSUE ANCHOR 5MM MODEL TA1005, ANCHOR INSERTER/SUTURE ORGANIZER 5MM AI1005, STABILIZER DRILL 5MM NONSTE— 510(k) K973031
Substantially EquivalentR. Thomas Grotz, M.D., Inc.
FDA 510(k) clearance K973031 for STABILIZER SOFT TISSUE ANCHOR 5MM MODEL TA1005, ANCHOR INSERTER/SUTURE ORGANIZER 5MM AI1005, STABILIZER DRILL 5MM NONSTE, Substantially Equivalent on 1997-11-03. Applicant: R. Thomas Grotz, M.D., Inc.. Device class: 1.
Clearance details
- Applicant
- R. Thomas Grotz, M.D., Inc.
- Product code
- Code MRI
- Device class
- Class 1
- Regulation
- 21 CFR 890.3490
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Francisco, CA, US
Recent devices under product code MRI
view allMore clearances from R. Thomas Grotz, M.D., Inc.
view all- K984200 — STABILIZER SOFT TISSUE ANCHOR, 5 AND 8MM; ANCHOR INSERTER, 5 AND 8MM; STABILIZER DRILL, 5 AND 8MM, NONSTERILE
- K965111 — STABILIZER SOFT TISSUE ANCHOR MODEL NUMBER TA1005, TA1008, ANCHOR INSERTER/SUTURE ORGANIZER MODEL NUMBERS AI1005, AI1008
- K964927 — STABILIZER SOFT TISSUE ANCHOR, 8MM MODEL TA1008, ANCHOR INSERTER/SUTURE ORGANIZER, 8MM MODEL AI1008, STABILIZER DRILL, 8
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