STELKAST 32MM MODULAR CERAMIC FEMORAL HEAD

Device Classification Name

prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented

510(k) Number K033944
Device Name STELKAST 32MM MODULAR CERAMIC FEMORAL HEAD
Applicant
STELKAST COMPANY
200 hidden valley rd.
mcmurray, 
PA 
15317

Applicant Contact donald a stevens
Correspondent
STELKAST COMPANY
200 hidden valley rd.
mcmurray, 
PA 
15317

Correspodent Contact donald a stevens
Regulation Number 888.3353
Classification Product Code
LZO  
Date Received 12/19/2003
Decision Date 03/12/2004
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No