FDA.reportPublic FDA data

Mini Superhawk

Primary DI
00811714036632
Brand
Mini Superhawk
Company
RESPONSIVE ORTHOPEDICS LLC
Model
285975
Catalog number
285975
Device description
Mini Superhawk Instrument Tray
Published
2025-12-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
FSMTray, Surgical, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811714036632PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811714036632008117140366328117140366320811714036632

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
002745858
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00811714036472Thunderbolt2859592859592026-07-31
00811714036489Thunderbolt2859602859602026-07-31
00811714036533Thunderbolt2859652859652025-05-14
00811714036540Thunderbolt2859662859662025-05-14
00811714036557Thunderbolt2859672859672025-05-14
00811714036564Thunderbolt2859682859682025-05-14
00811714036571Thunderbolt2859692859692025-05-14
00811714036588Thunderbolt2859702859702025-05-14
00811714036595Thunderbolt2859712859712025-05-14
00811714036601Thunderbolt2859722859722025-05-14
00811714036618Thunderbolt2859732859732025-05-14
00811714036403Shadow Mini Instruments2859522859522026-02-03
00811714036427Shadow Knotless Instruments2859542859542026-02-03
00811714036397Shadow Mini All-Suture Anchor2859512859512025-05-14
00811714036380Shadow Instruments2859502859502025-12-31
00811714036373Shadow All-Suture Anchor2859492859492025-05-14
00811714036625Mini Superhawk Suture Anchor2859802859802025-12-09
00811714036663Mini Superhawk2859782859782025-12-09
00811714036670Mini Superhawk2859792859792025-12-09
00811714036731Osprey Suture Anchor2859852025-12-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07640221370884TRYPTIK® TiSpineArt SAFSM2026-08-27
07613327630602MakoMAKO SURGICAL CORP.FSM2026-08-25
00724995296216V. MuellerSteris CorporationFSM2026-08-21
00724995296223V. MuellerSteris CorporationFSM2026-08-21
00724995296230V. MuellerSteris CorporationFSM2026-08-21
00724995296247V. MuellerSteris CorporationFSM2026-08-21
00724995296254V. MuellerSteris CorporationFSM2026-08-21
00724995296261V. MuellerSteris CorporationFSM2026-08-21
00724995296278V. MuellerSteris CorporationFSM2026-08-21
00724995296285V. MuellerSteris CorporationFSM2026-08-21
00724995296292V. MuellerSteris CorporationFSM2026-08-21
00724995296308V. MuellerSteris CorporationFSM2026-08-21
00724995296315V. MuellerSteris CorporationFSM2026-08-21
00724995296322V. MuellerSteris CorporationFSM2026-08-21
00724995296339V. MuellerSteris CorporationFSM2026-08-21
00724995296346V. MuellerSteris CorporationFSM2026-08-21
00724995296353V. MuellerSteris CorporationFSM2026-08-21
00724995296360V. MuellerSteris CorporationFSM2026-08-21
00724995296377V. MuellerSteris CorporationFSM2026-08-21
00724995296384V. MuellerSteris CorporationFSM2026-08-21
00724995296391V. MuellerSteris CorporationFSM2026-08-21
00724995296407V. MuellerSteris CorporationFSM2026-08-21
00724995296414V. MuellerSteris CorporationFSM2026-08-21
00724995296421V. MuellerSteris CorporationFSM2026-08-21
00724995296438V. MuellerSteris CorporationFSM2026-08-21
00724995296445V. MuellerSteris CorporationFSM2026-08-21
00724995296452V. MuellerSteris CorporationFSM2026-08-21
00724995296469V. MuellerSteris CorporationFSM2026-08-21
00724995296476V. MuellerSteris CorporationFSM2026-08-21
00724995296483V. MuellerSteris CorporationFSM2026-08-21