Skip to content

Nighthawk 90-RAA-860100

by Responsive Orthopedics LLC

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K190446

FDA submission, from GUDID

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00811714030265 UDI-DI Date24 Jul 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK190446 Date27 Mar 2019DecidedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Nighthawk
Generic name
Tendon/ligament bone anchor, non-bioabsorbable
Model / Ref / Catalog
90-RAA-860100
Primary DI / UDI-DI
00811714030265
510(k) Number
FDA product code
MBI
GMDN term
Tendon/ligament bone anchor, non-bioabsorbable
Device class
Class II
Regulation number
888.3040
GUDID distribution status
In Commercial Distribution

Related devices

Category: Tendon/ligament bone anchor, non-bioabsorbable

Cleared under the same submission (K190446)

Other devices from Responsive Orthopedics LLC

See all devices from Responsive Orthopedics LLC →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date

Other properties (8)

  • Sterilise before use: No
  • Contains latex: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No