510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K101827Substantially Equivalent

Osteoscaf

Texas Innovative Medical Devices (dba) Skeletal, San Antonio TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K101827 is the FDA 510(k) clearance record for OSTEOSCAF, a class II device, cleared for Texas Innovative Medical Devices (Dba) Skeletal on under FDA product code LYC (Bone Grafting Material, Synthetic). FDA's definition for product code LYC reads: "A synthetic bone grafting material is synthetically-derived device, such as hydroxylapatite, intended to fill, augment, or reconstruct periodontal and or bony defects of the upper or lower jaw". FDA records list one 510(k) clearance for Texas Innovative Medical Devices (Dba) Skeletal. As of , FDA records show no recalls naming K101827.

Clearance record

Decision date
Received
(293 days to decision)
Product code
LYC Bone Grafting Material, Synthetic
Regulation
21 CFR 872.3930
Device class
Class II
Review panel
Dental
Applicant
Texas Innovative Medical Devices (Dba) Skeletal 4808 Research Dr., San Antonio TX
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LYC

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