510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K101356Substantially Equivalent

Spacer-G and Spacer-K

Tecres SpA, Rockville MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K101356 is the FDA 510(k) clearance record for Spacer-G and Spacer-K, a class II device, cleared for Tecres S.P.A. on under FDA product code KWL (Prosthesis, Hip, Hemi-, Femoral, Metal). FDA records list 15 510(k) clearances for Tecres S.P.A., from to . As of , FDA records show no recalls naming K101356.

Clearance record

Decision date
Received
(494 days to decision)
Product code
KWL Prosthesis, Hip, Hemi-, Femoral, Metal
Regulation
21 CFR 888.3360
Device class
Class II
Review panel
Orthopedic
Applicant
Tecres S.P.A. 7 Trl. House Ct., Rockville MD
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KWL

Trailing 12 months
3 clearances under product code KWL in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KWL, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20261
August 20260
September 20260
October 20260