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Skeletal Dynamics, Inc

Active in EUDAMED
Also registered as Skeletal Dynamics, Skeletal Dynamics, LLC

United Statesfrom SRN EUDAMED FDA SRN US-MF-000041441 FEI 3006742481

Devices
172
Registrations
EUDAMEDFDA
FDA recalls
1

At a glance

Counted by deviCERTS from registry records

EU certificates

1 of 1 in force.

See certificates

Market reach

European Union
EUDAMED actor, 1 certificate
United States
FDA FEI, FDA recalls

Catalogue172

Newest first, rows 1-50 of 172

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Rows 1-50 of 172

Showing 1-50 of 172

Company details

EUDAMED SRN
US-MF-000041441
FDA FEI number
3006742481
EUDAMED status
Active
EUDAMED registered name
Skeletal Dynamics, Inc.
EUDAMED abbreviated name
Skeletal Dynamics
Registered address
7300, N Kendall Drive, 33156, Miami, United States
Phone
+1 305 596 7585
PRRC contact
Mario Arbesu(public in EUDAMED)

EUDAMED certificates1

1 certificate1 valid, 0 expiredMDR 1next expiry 25 Mar 2030

EUDAMED certificates (1)

Notified body 2797 1 certificate

  • MDR 813151 Issued

    Quality management system EU MDR

    Issued
    26 Mar 2025
    Expires
    25 Mar 2030

FDA recalls1

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

  • 2014

    • 16 Oct 2014 Z-0582-2015 Class II Terminated Report received where the Align Radial Stem fractured. Distribution: Nationwide Distribution including GA, NJ, NM, IL, CA, OK, CO, NY, LA, OH, FL, VA, MD, MS, TX, IA, AL, WA, TN, ME, CT,…
      Full distribution text Nationwide Distribution including GA, NJ, NM, IL, CA, OK, CO, NY, LA, OH, FL, VA, MD, MS, TX, IA, AL, WA, TN, ME, CT, WI, AZ, NE, SC, NC and Puerto Rico.
      Submission number: K092721

Frequently asked questions

How many devices does SKELETAL DYNAMICS, INC have in the registry?

The registry currently lists 172 devices for SKELETAL DYNAMICS, INC. Devices recorded under merged duplicate company entries are counted once.

Which registries list SKELETAL DYNAMICS, INC's devices?

Among its 50 most recently registered devices, SKELETAL DYNAMICS, INC has devices listed in EUDAMED (50 devices).

What risk classes do SKELETAL DYNAMICS, INC's devices fall under?

Among its 50 most recently registered devices, the classes recorded for SKELETAL DYNAMICS, INC's devices are Class I and Class IIa. Each device page shows its own class and authorisation.

Are there FDA recall records for SKELETAL DYNAMICS, INC?

FDA recall records list 1 recall initiated by SKELETAL DYNAMICS, INC, the most recent initiated on 2014-10-16. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What EUDAMED certificates are recorded for SKELETAL DYNAMICS, INC?

EUDAMED lists 1 certificate for SKELETAL DYNAMICS, INC (quality management system) under MDR. 1 is recorded with the status issued. The most recent was issued on 2025-03-26.

What are the newest devices from SKELETAL DYNAMICS, INC in the registry?

The most recently registered devices listed for SKELETAL DYNAMICS, INC include Skeletal Dynamics Guides, Skeletal Dynamics Bone Contouring Instruments, Skeletal Dynamics Surgical Screwdriver and Skeletal Dynamics Single-use Surgical Drills.

Generated automatically from registry data and not verified by a human reviewer.