510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K094035Substantially Equivalent

Exp Acetabular Liner, Models Sc3342 Non-Hooded 28Mm, Sc3343 Hooded 28Mm

Globus Medical, Inc., Mcmurray PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K094035 is the FDA 510(k) clearance record for EXP ACETABULAR LINER, MODELS SC3342 NON-HOODED 28MM, SC3343 HOODED 28MM, a class II device, cleared for Stelkast Company on under FDA product code OQG (Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented). FDA's definition for product code OQG reads: "1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis. 3. Correction of functional deformity. 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of...". FDA records list 217 510(k) clearances for GLOBUS MEDICAL, INC., from to . As of , FDA records show no recalls naming K094035.

Clearance record

Decision date
Received
(449 days to decision)
Product code
OQG Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented
Regulation
21 CFR 888.3358
Device class
Class II
Review panel
Orthopedic
Applicant
Stelkast Company 200 Hidden Valley Rd., Mcmurray PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OQG

Trailing 12 months

FDA records hold no clearances under product code OQG in the trailing twelve months.

FDA records show no clearances under product code OQG in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OQG, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260