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DynaNail 1200-01-1230

by Medshape, Inc. 2 variants

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 2 Nov 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 2 Nov 2026. What this means

Regulatory status

as of registry sync 2 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberM97012000112300 UDI-DI Date16 Oct 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 2 Nov 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
DynaNail
Generic Name
Arthrodesis intramedullary nail, non-distracting
Model / Reference
1200-01-1230
Primary DI / UDI-DI
M97012000112300
510(k) Number
FDA Product Code
HSB
GMDN Term
Arthrodesis intramedullary nail, non-distracting
Device Class
Class II
Regulation Number
888.3020
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Other devices from Medshape, Inc.

See all devices from Medshape, Inc. →

Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number

Other properties (9)

  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No