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Baha 93332

by Cochlear Bone Anchored Solutions AB

Baha 93332 is a Class II device made by Cochlear Bone Anchored Solutions AB, cleared under FDA 510(k) K121317 on 12 Oct 2012 and listed in FDA GUDID since 9 Oct 2015 (UDI-DI 09321502022729), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K121317

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number09321502022729 UDI-DI Date9 Oct 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK121317 Date12 Oct 2012DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K121317 decided 12 Oct 2012 Active
  • FDA GUDID UDI-DI 09321502022729 listed 9 Oct 2015 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K121317
  2. Listed FDA GUDID 09321502022729

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Baha
Generic name
Craniofacial bone screw, non-bioabsorbable
Model / Ref / Catalog
93332
Primary DI / UDI-DI
09321502022729
510(k) Number
FDA product code
MAH
GMDN term
Craniofacial bone screw, non-bioabsorbable
Device class
Class II
Regulation number
874.3302
GUDID distribution status
In Commercial Distribution
Sterilisation method
Radiation Sterilization
MRI safety
MR Conditional
Size
Length — 14 Millimeter

Related devices

Category: Craniofacial bone screw, non-bioabsorbable

Cleared under the same submission (K121317)

and 5 more cleared under K121317

Similar devices in this category

Other devices filed under Craniofacial bone screw, non-bioabsorbable.

Other devices from Cochlear Bone Anchored Solutions AB

See all devices from Cochlear Bone Anchored Solutions AB →

Properties

  • Supplied sterile
  • Sterilise before use
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (8, all answered No)