FDA.report

Symmetry Surgical

Primary DI
00887482013649
Brand
Symmetry Surgical
Company
SYMMETRY SURGICAL INC.
Model
46-3002
Device description
Symmetry® Set, Symmetry Spondylophyte
Published
2024-09-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
HWAImpactor

Product Code Classifications

CodeDeviceSpecialtyClass
HWAImpactorOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00887482013649PrimaryGS10

GMDN Terms

TermDefinition
General surgical procedure kit, non-medicated, reusableA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
079641356
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00887482196533Symmetry Barraquer60-1906-SYM60-1906-SYM2025-07-24
00887482196540Symmetry Castroviejo60-1910-SYM60-1910-SYM2025-07-24
00887482012307Symmetry Tyrell 38-652538-65252022-09-16
00887482006559Symmetry Surgical32-348532-34852024-09-05
00887482006566Symmetry Surgical32-348532-34852024-09-05
00887482196793Symmetry Surgical90-1042R90-1042R2024-09-05
00887482030578Symmetry Hardy80-133080-13302024-09-05
00887482030585Symmetry Hardy80-133180-13312024-09-05
00887482030592Symmetry Hardy80-133280-13322024-09-05
00887482030608Symmetry Hardy80-133380-13332024-09-05
00887482030615Symmetry Hardy80-133480-13342024-09-05
00887482030622Symmetry Hardy80-133580-13352024-09-05
00887482030707Symmetry Hardy80-134580-13452024-09-05
00887482030714Symmetry Hardy80-134680-13462024-09-05
00887482030721Symmetry Hardy80-134780-13472024-09-05
00887482030738Symmetry Hardy80-134880-13482024-09-05
00887482031124Symmetry Verity™80-153680-15362024-09-05
00887482031506Symmetry Rhoton®80-169280-16922024-09-05
00887482031513Symmetry Rhoton®80-169380-16932024-09-05
00887482116203Symmetry Paparella61-377561-37752024-09-05

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
10885862648150EquinoxeExactech, Inc.HWA2026-03-19
09421038412220Enztec XR Trinket M8X1.0-01ENZTEC LIMITEDHWA2026-03-13
00840277133403Innomed, Inc.INNOMED, INC.HWA2026-03-11
00810123209934Adler Instrument CompanyAdler, Inc.HWA2026-03-03
05056405508578Charnley Femoral Prosthesis PusherPLATTS & NISBETT LIMITEDHWA2026-02-11
00822409133178N/AOrtho Development CorporationHWA2026-02-05
00822409133185N/AOrtho Development CorporationHWA2026-02-05
00822409133192N/AOrtho Development CorporationHWA2026-02-05
00822409133215N/AOrtho Development CorporationHWA2026-02-05
10603295554974EMPHASYSDEPUY ORTHOPAEDICS, INC.HWA2026-02-04
04026575048168General InstrumentWALDEMAR LINK GmbH & Co. KGHWA2026-02-02
04026575080182General InstrumentWALDEMAR LINK GmbH & Co. KGHWA2026-02-02
08800017299358BENCOX Surgical InstrumentsCorentec Co., LtdHWA2026-01-12
08806373887734BENCOX Surgical InstrumentsCorentec Co., LtdHWA2026-01-12
08806373887826BENCOX Surgical InstrumentsCorentec Co., LtdHWA2026-01-12
08806373887833BENCOX Surgical InstrumentsCorentec Co., LtdHWA2026-01-12
08806373888021BENCOX Surgical InstrumentsCorentec Co., LtdHWA2026-01-12
08806373888045BENCOX Surgical InstrumentsCorentec Co., LtdHWA2026-01-12
09421028112536Enztec Classic OCI - Trinket 5/16-24 UNF-02ENZTEC LIMITEDHWA2026-01-12
09421028113540Enztec Classic OCI - Trinket 3/8-16 UNC-01ENZTEC LIMITEDHWA2026-01-12
09421028113557Enztec Classic OCI - Trinket 5/16-24 UNF-01ENZTEC LIMITEDHWA2026-01-12
09421028113571Enztec Classic OCI - Trinket 3/8-24 UNF-01ENZTEC LIMITEDHWA2026-01-12
04026575448500General InstrumentWALDEMAR LINK GmbH & Co. KGHWA2025-11-07
04026575448517General InstrumentWALDEMAR LINK GmbH & Co. KGHWA2025-11-07
04026575448524General InstrumentWALDEMAR LINK GmbH & Co. KGHWA2025-11-07
09421038410516 ATTUNE FEMORAL IMPACTORENZTEC LIMITEDHWA2025-10-21
09421038410523ATTUNE FEMORAL IMPACTOR HEADENZTEC LIMITEDHWA2025-10-21
00190446924470DJO SURGICALEncore Medical, L.P.HWA2025-10-10
09309000394289MAC SurgicalMAC SURGICAL PTY LTDHWA2025-09-30
09309000394296MAC SurgicalMAC SURGICAL PTY LTDHWA2025-09-30