510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K920037Substantially Equivalent

Osteo Compression Hip Screw

Osteo AG, Greenwood SC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K920037 is the FDA 510(k) clearance record for OSTEO COMPRESSION HIP SCREW, a class II device, cleared for Osteo AG on under FDA product code HRC (Sterilizer, Soft-Lens, Thermal, Battery-Powered). FDA records list 9 510(k) clearances for Osteo AG, from to . As of , FDA records show no recalls naming K920037.

Clearance record

Decision date
Received
(65 days to decision)
Product code
HRC Sterilizer, Soft-Lens, Thermal, Battery-Powered
Regulation
21 CFR 886.5928
Device class
Class II
Review panel
Ophthalmic
Applicant
Osteo AG 208 Wilson Bridge Rd., Greenwood SC
510(k) summary
Statement
Third party review
No

Clearances, product code HRC

Trailing 12 months

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

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